Randomized Multicenter Phase II Trial of a Biweekly Regimen of Fluorouracil and Leucovorin (LV5FU2), LV5FU2 Plus Cisplatin, or LV5FU2 Plus Irinotecan in Patients With Previously Untreated Metastatic Gastric Cancer: A Fédération Francophone de Cancérologie Digestive Group Study—FFCD 9803

2004 ◽  
Vol 22 (21) ◽  
pp. 4319-4328 ◽  
Author(s):  
Olivier Bouché ◽  
Jean Luc Raoul ◽  
Franck Bonnetain ◽  
Marc Giovannini ◽  
Pierre Luc Etienne ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Progression Free Survival ◽  
Metastatic Gastric Cancer ◽  
Phase Iii ◽  
Survival Times ◽  
Multicenter Phase ◽  
Independent Expert ◽  
Phase Iii Study ◽  
Cancérologie Digestive

Purpose To determine the efficacy and safety of a biweekly regimen of leucovorin (LV) plus fluorouracil (FU) alone or in combination with cisplatin or irinotecan in patients with previously untreated metastatic gastric adenocarcinoma and to select the best arm for a phase III study. Patients and Methods One hundred thirty-six patients (two were ineligible) were enrolled onto the randomized multicenter phase II trial. Patients received LV 200 mg/m2 (2-hour infusion) followed by FU 400 mg/m2 (bolus) and FU 600 mg/m2 (22-hour continuous infusion) on days 1 and 2 every 14 days (LV5FU2; arm A), LV5FU2 plus cisplatin 50 mg/m2 (1-hour infusion) on day 1 or 2 (arm B), or LV5FU2 plus irinotecan 180 mg/m2 (2-hour infusion) on day 1 (arm C). Results The overall response rates, which were confirmed by an independent expert panel, were 13% (95% CI, 3.4% to 23.3%), 27% (95% CI, 14.1% to 40.4%), and 40% (95% CI, 25.7% to 54.3%) for arms A, B, and C, respectively. Median progression-free survival and overall survival times were 3.2 months (95% CI, 1.8 to 4.6 months) and 6.8 months (95% CI, 2.6 to 11.1 months) with LV5FU2, respectively; 4.9 months (95% CI, 3.5 to 6.3 months) and 9.5 months (95% CI, 6.9 to 12.2 months) with LV5FU2-cisplatin, respectively; and 6.9 months (95% CI, 5.5 to 8.3 months) and 11.3 months (95% CI, 9.3 to 13.3 months) with LV5FU2-irinotecan, respectively. Conclusion Of the three regimens tested, the combination of LV5FU2-irinotecan is the most promising and will be assessed in a phase III trial.

Phase II Trial of 4′-Epi-Doxorubicin in Locally Advanced or Metastatic Gastric Cancer

1988 ◽  
Vol 74 (3) ◽  
pp. 313-315 ◽  
Author(s):  
Eduardo Cazap ◽  
Roberto Estevez ◽  
Mario Bruno ◽  
Daniel Levy ◽  
Carlos Algamiz ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Gastric Adenocarcinoma ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Metastatic Gastric Cancer ◽  
Phase Iii ◽  
Future Studies ◽  
Phase Iii Trials

Patients with locally advanced or metastatic gastric adenocarcinoma received an i.v. bolus of 4′-epi-doxorubicin, 75/mg/m2/cycle, every 21 days. Partial responses were observed in 5 of 23 evaluable patients (21.7%). Treatment was generally well tolerated and toxicity was mild. The response rate to epirubicin appears to be very similar to that reported for doxorubicin. Larger doses of epirubicin could be safely used in future studies, and further evaluation of epirubicin in phase III trials is indicated.

Docetaxel, Cisplatin, and Fluorouracil; Docetaxel and Cisplatin; and Epirubicin, Cisplatin, and Fluorouracil As Systemic Treatment for Advanced Gastric Carcinoma: A Randomized Phase II Trial of the Swiss Group for Clinical Cancer Research

2007 ◽  
Vol 25 (22) ◽  
pp. 3217-3223 ◽  
Author(s):  
Arnaud D. Roth ◽  
Nicola Fazio ◽  
Roger Stupp ◽  
Stephen Falk ◽  
Jürg Bernhard ◽  
...  
Keyword(s):  
Gastric Carcinoma ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Performance Status ◽  
Infectious Complications ◽  
Phase Iii ◽  
Survival Times ◽  
Clinical Cancer Research ◽  
Advanced Gastric Carcinoma ◽  
Randomized Phase Ii

PurposeThis randomized phase II trial evaluated two docetaxel-based regimens to see which would be most promising according to overall response rate (ORR) for comparison in a phase III trial with epirubicin-cisplatin-fluorouracil (ECF) as first-line advanced gastric cancer therapy.Patients and MethodsChemotherapy-naïve patients with measurable unresectable and/or metastatic gastric carcinoma, a performance status ≤ 1, and adequate hematologic, hepatic, and renal function randomly received ≤ eight 3-weekly cycles of ECF (epirubicin 50 mg/m2on day 1, cisplatin 60 mg/m2on day 1, and fluorouracil [FU] 200 mg/m2/d on days 1 to 21), TC (docetaxel initially 85 mg/m2on day 1 [later reduced to 75 mg/m2as a result of toxicity] and cisplatin 75 mg/m2on day 1), or TCF (TC plus FU 300 mg/m2/d on days 1 to 14). Study objectives included response (primary), survival, toxicity, and quality of life (QOL).ResultsORR was 25.0% (95% CI, 13% to 41%) for ECF, 18.5% (95% CI, 9% to 34%) for TC, and 36.6% (95% CI, 23% to 53%) for TCF (n = 119). Median overall survival times were 8.3, 11.0, and 10.4 months for ECF, TC, and TCF, respectively. Toxicity was acceptable, with one toxic death (TC arm). Grade 3 or 4 neutropenia occurred in more treatment cycles with docetaxel (TC, 49%; TCF, 57%; ECF, 34%). Global health status/QOL substantially improved with ECF and remained similar to baseline with both docetaxel regimens.ConclusionTime to response and ORR favor TCF over TC for further evaluation, particularly in the neoadjuvant setting. A trend towards increased myelosuppression and infectious complications with TCF versus TC or ECF was observed.

Randomized, Double-Blind Phase II Trial With Prospective Classification by ATM Protein Level to Evaluate the Efficacy and Tolerability of Olaparib Plus Paclitaxel in Patients With Recurrent or Metastatic Gastric Cancer

2015 ◽  
Vol 33 (33) ◽  
pp. 3858-3865 ◽  
Author(s):  
Yung-Jue Bang ◽  
Seock-Ah Im ◽  
Keun-Wook Lee ◽  
Jae Yong Cho ◽  
Eun-Kee Song ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Progression Free Survival ◽  
Metastatic Gastric Cancer ◽  
Phase Iii ◽  
Double Blind Study ◽  
Double Blind ◽  
Gastric Cancer Cell Lines ◽  
Study Population ◽  
Atm Protein

Purpose Gastric cancer cell lines, particularly those with low levels of ataxia telangiectasia mutated (ATM), a key activator of DNA damage response, are sensitive to the poly (ADP-ribose) polymerase inhibitor olaparib. We compared the efficacy of olaparib plus paclitaxel (olaparib/paclitaxel) with paclitaxel alone in patients with recurrent or metastatic gastric cancer and assessed whether low ATM expression is predictive of improved clinical outcome for olaparib/paclitaxel. Patients and Methods In this phase II, double-blind study (Study 39; NCT01063517), patients were randomly assigned to oral olaparib 100 mg twice per day (tablets) plus paclitaxel (80 mg/m2 per day intravenously on days 1, 8, and 15 of every 28-day cycle) or placebo plus paclitaxel (placebo/paclitaxel), followed by maintenance monotherapy with olaparib (200 mg twice per day) or placebo. The study population was enriched to 50% for patients with low or undetectable ATM levels (ATMlow). Primary end point was progression-free survival (PFS). Results One hundred twenty-three of 124 randomly assigned patients received treatment (olaparib/paclitaxel, n = 61; placebo/paclitaxel, n = 62). The screening prevalence of ATMlow patients was 14%. Olaparib/paclitaxel did not lead to a significant improvement in PFS versus placebo/paclitaxel (overall population: hazard ratio [HR], 0.80; median PFS, 3.91 v 3.55 months, respectively; ATMlow population: HR, 0.74; median PFS, 5.29 v 3.68 months, respectively). However, olaparib/paclitaxel significantly improved overall survival (OS) versus placebo/paclitaxel in both the overall population (HR, 0.56; 80% CI, 0.41 to 0.75; P = .005; median OS, 13.1 v 8.3 months, respectively) and the ATMlow population (HR, 0.35; 80% CI, 0.22 to 0.56; P = .002; median OS, not reached v 8.2 months, respectively). Olaparib/paclitaxel was generally well tolerated, with no unexpected safety findings. Conclusion Olaparib/paclitaxel is active in the treatment of patients with metastatic gastric cancer, with a greater OS benefit in ATMlow patients. A phase III trial in this setting is under way.

Bevacizumab Plus Irinotecan in Recurrent Glioblastoma Multiforme

2007 ◽  
Vol 25 (30) ◽  
pp. 4722-4729 ◽  
Author(s):  
James J. Vredenburgh ◽  
Annick Desjardins ◽  
James E. Herndon ◽  
Jennifer Marcello ◽  
David A. Reardon ◽  
...  
Keyword(s):  
Glioblastoma Multiforme ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Progression Free Survival ◽  
Recurrent Glioblastoma ◽  
Phase Iii ◽  
Vascular Endothelial ◽  
Recurrent Glioblastoma Multiforme ◽  
Initial Cohort ◽  
Endothelial Growth Factor

Purpose The prognosis for patients with recurrent glioblastoma multiforme is poor, with a median survival of 3 to 6 months. We performed a phase II trial of bevacizumab, a monoclonal antibody to vascular endothelial growth factor, in combination with irinotecan. Patients and Methods This phase II trial included two cohorts of patients. The initial cohort, comprising 23 patients, received bevacizumab at 10 mg/kg plus irinotecan every 2 weeks. The dose of irinotecan was based on the patient's anticonvulsant: Patients taking enzyme-inducing antiepileptic drugs (EIAEDs) received 340 mg/m2, and patients not taking EIAEDs received 125 mg/m2. After this regimen was deemed safe and effective, the irinotecan schedule was changed to an accepted brain tumor regimen of four doses in 6 weeks, in anticipation of a phase III randomized trial of irinotecan versus irinotecan and bevacizumab. The second cohort, comprising 12 patients, received bevacizumab 15 mg/kg every 21 days and irinotecan on days 1, 8, 22, and 29. Each cycle was 6 weeks long and concluded with patient evaluations, including magnetic resonance imaging. Results The 6-month progression-free survival among all 35 patients was 46% (95% CI, 32% to 66%). The 6-month overall survival was 77% (95% CI, 64% to 92%). Twenty of the 35 patients (57%; 95% CI, 39% to 74%) had at least a partial response. One patient developed a CNS hemorrhage, which occurred in his 10th cycle. Four patients developed thromboembolic complications (deep venous thrombosis and/or pulmonary emboli). Conclusion Bevacizumab and irinotecan is an effective treatment for recurrent glioblastoma multiforme and has moderate toxicity.

Multicenter phase II trial of temsirolimus (TEM) and bevacizumab (BEV) in pancreatic neuroendocrine tumor (PNET).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 260-260 ◽  
Author(s):  
Timothy J. Hobday ◽  
Rui Qin ◽  
Diane Lauren Reidy ◽  
Malcolm J Moore ◽  
Jonathan R. Strosberg ◽  
...  
Keyword(s):  
Phase Ii ◽  
Mtor Inhibitor ◽  
Phase Ii Trial ◽  
Objective Response ◽  
Progression Free Survival ◽  
Pancreatic Neuroendocrine Tumor ◽  
Phase Iii ◽  
Study Entry ◽  
Targeted Agents ◽  
Ecog Ps

260 Background: Recent placebo-controlled phase III trials of the mTOR inhibitor everolimus and the VEGF/ PDGF receptor inhibitor sunitinib in PNET noted improved progression-free survival (PFS). However, objective response rates (RR) with these agents are <10%. Preclinical studies suggest enhanced anti-tumor effects with combined mTOR and VEGF targeted therapy. Methods: We conducted a phase II trial of the mTOR inhibitor TEM (25 mg IV q week) and the VEGF-A monoclonal antibody BEV (10 mg/kg IV q 2 weeks) in patients (pts) with well or moderately differentiated PNET and progressive disease by RECIST within 7 months of study entry. Co-primary endpoints were RR and 6-month PFS. Planned enrollment is 50 patients, with interim analysis after the first 25 evaluable pts. Pts had no prior mTOR or VEGF targeted agents, ECOG PS 0-1, and adequate hematologic and organ function. Continued octreotide was allowed, but not required. Prior interferon, embolization, and ≤ 2 chemotherapy regimens were allowed. Results: Confirmed PR was documented in 11 of the first 25 (44%) evaluable patients. 20 of 25 (80%) patients were progression-free at 6 months. Both endpoints exceeded pre-defined criteria to continue enrollment. For 35 evaluable patients, the most common grade 3-4 adverse events attributed to therapy were leukopenia (12%), hypertension (12%), hyperglycemia (12%), mucositis (9%), and fatigue (9%). Conclusions: The combination of TEM/BEV has substantial activity in a multi-center phase II trial with RR of 44%, well in excess of single targeted agents in PNET. 6-month PFS was a notable 80% in a population of patients with RECIST criteria progression within 7 months of study entry. Accrual is ongoing. Supported by NCI N01 Contracts: 662205, 62203, 62208, 62209, 62206, 62204, 62207, 62201.

Lapatinib in combination with ECF/x in EGFR1 positive first-line metastatic gastric cancer (GC): A phase II randomized placebo controlled trial (EORTC 40071).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS4140-TPS4140
Author(s):  
Markus Hermann Moehler ◽  
Arno Schad ◽  
Murielle E. Mauer ◽  
Michel Praet ◽  
Francisco J. Sapunar ◽  
...  
Keyword(s):  
Phase Ii ◽  
Controlled Trial ◽  
Cohort Analysis ◽  
Progression Free Survival ◽  
Metastatic Gastric Cancer ◽  
Phase Iii ◽  
Her2 Status ◽  
Clinical Activity ◽  
Curative Surgery ◽  
Double Blind

TPS4140 Background: Survival of HER2+ metastatic GC is prolonged by trastuzumab when administered with CF/X (VanCutsem, ASCO 2009). Lapatinib inhibits both EGFR1 and HER2, is active in HER2+ GC lines, and has shown clinical activity in uncontrolled phase II GC trials. A phase III trial of lapatinib with X + oxaliplatin in HER2+ (FISH) GC is closed to recruitment. Additional unaddressed questions include the efficacy and safety of lapatinib with ECF/X (epirubicin + cisplatin + 5-FU or capecitabine (X), which is a preferred chemotherapy (CT) regimen in GC), and its activity in patients (pts) with discordant FISH or IHC HER2 status or EGFR1+. Methods: This is a phase II, randomized, double- blind, placebo controlled, multicenter trial sponsored by the EORTC. About 480 pts with adenocarcinoma of the stomach or esophagogastric junction not amenable to curative surgery and without prior palliative CT are screened centrally for HER2/EGFR1 by FISH and IHC. Patients are enrolled into one of two strata: 1) HER2 FISH- and IHC 2/3+, or 2) HER2 IHC 0/+ and EGFR1 FISH+ or IHC 2/3+. Pts HER2 FISH+/IHC 2/3+ and pts without HER2/EGFR1 by FISH/IHC will be excluded. 168 pts are anticipated to be randomized to lapatinib 1,250 mg cont. until progression or placebo, administered 6 cycles of ECF or ECX (72/96 in stratum 1/2, respectively).The primary endpoint is progression-free survival (PFS) in stratum 2 and 77 events are needed for 80% power to detect an increase in PFS from 4 to 6.5 months with lapatinib (HR=0.615, one-sided alpha 10%). Secondary endpoints include PFS, toxicity, response rate, overall survival, and correlation of HER2/EGFR1 status with response. Currently, half of all screened patients (19/38) have been randomized. So far, 8/38 (21%) pts were HER2+ according TOGA criteria. By FISH or IHC, 14/38 were EGFR1+, with 4/14 pts double HER2/EGFR+. Enrolment continues in 5 centers with about 4-10 patients per month. A safety cohort analysis will be performed in the first 15 pts receiving lapatinib. Conclusions: This is the first trial to analyze prospectively and separately the role of lapatinib combined with chemotherapy in EGFR1+ GC pts stratified by FISH/ IHC.

A Phase II Trial of Bendamustine, Bortezomib, and Rituximab in Patients with Previously Untreated Low Grade Lymphoma

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1492-1492
Author(s):  
Ian W. Flinn ◽  
Thomas J. Ervin ◽  
Ralph V. Boccia ◽  
Douglas B. Flora ◽  
J. Daniel Cuevas ◽  
...  
Keyword(s):  
Phase Ii ◽  
Research Funding ◽  
Phase Ii Trial ◽  
Cell Lymphoma ◽  
Progression Free Survival ◽  
Lymph Node Biopsy ◽  
Phase Iii ◽  
Low Grade ◽  
First Line ◽  
Stroke Treatment

Abstract Introduction: Rituximab and bendamustine combination regimens have demonstrated high activity in non-Hodgkin's lymphoma (NHL). Phase III trials evaluating bendamustine plus rituximab as first-line therapy for patients (pts) with indolent and mantle cell lymphoma have shown equivalent or superior results when compared to R-CHOP or R-CVP as first-line treatment for indolent lymphoma. The proteasome inhibitor, bortezomib, has shown substantial activity in multiple myeloma and has demonstrated synergy and/or ability to overcome resistance to a variety of current and investigational treatments for lymphoma. A Phase II study of the combination of bendamustine, bortezomib, and rituximab (BBR) in relapse/refractory indolent and mantel cell NHL pts resulted in an ORR of 83% and 47% 2yr PFS (Friedberg, Blood 2011). This Phase II trial evaluated the activity of BBR in patients with previously untreated low-grade lymphoma. Methods: Eligible patients had histologically-confirmed follicular center cell lymphoma (FL) (grade 1 or 2), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), or lymphoplasmacytic lymphoma (LPL); lymph node biopsy containing CD20+ B-cells; Ann-Arbor Stage 2, 3, or 4 disease; no previous systemic treatment for lymphoma; bi-dimensional measurable disease with at least 1 lesion measuring > 2.0 cm in a single dimension; ECOG PS 0-2. Treatment for all patients was given in 28-day cycles for a maximum of 6 cycles. Patients received rituximab 375 mg/m2 IV on days 1, 8, and 15 of cycle 1 (cycles 2-6, rituximab only on day 1); bendamustine 90 mg/m2 IV on days 1 and 2; and bortezomib 1.6 mg/m2 IV on days 1, 8, and 15. Response evaluations were performed after cycle 3 and cycle 6. Patients were permitted to begin maintenance treatment with rituximab 6 months after completion of study treatment and after 6-month follow-up assessments have been conducted. The primary endpoint was to determine the CR rate in this patient population. Secondary endpoints were to assess the ORR, PFS and to characterize the toxicity of this drug combination. Results: Between 3/2010 and 11/2011, 55 patients were enrolled, median age of 64 years (range 30-89), 51% male, 85% stage III or IV. Diagnoses were: FL, 38pts (69%); MZL, 8pts (15%); LPL, 5pts (9%); SLL, 4pts (7%). FLIPI risk for FL pts was low 14 pts (37%), intermediate 18 pts (47%), and high 6 pts (16%). Forty-four pts (80%) completed 6 cycles of BRR, and 67% continued to maintenance rituximab with 35% completing maintenance. The most common grade (G) 3/4 hematologic toxicities were leukopenia (29%), neutropenia (29%) and lymphopenia (16%), and the most common G 3/4 non-hematologic toxicities were neuropathy (9%), diarrhea (7%), and fatigue (7%) (See Table 1). There were no treatment-related deaths and 1 unrelated death on study (embolic stroke). Treatment discontinuation due to toxicity occurred in 11% of pts (2 pts neuropathy, 1 pt each: pancreatitis, atrial fibrillation, erythemia multiforme, and diarrhea). Fifty-one pts were evaluable for response, including 36 FL pts. The overall response rate was 94% (CR 65%, PR 29%) for all pts and 94% (CR 67%, PR 27%) for FL pts. The median FU was 34.8 months (range 9-49). Kaplan-Meier estimates of all pts for progression-free survival (PFS) and overall survival (OS) at 36 mos were 75% and 88% respectively. The 36 mo PFS and OS estimates for FL pts were 73% and 89% respectively. Conclusion: BBR was well tolerated, produced high CR and OR rates and response compares favorably with Phase III of BR. No unforeseen toxicities were noted with this combination. Further study of this regimen in patients with previously untreated low-grade lymphoma is warranted. Table 1. G3/4 Toxicity Hematologic G3 G4 Total Leukopenia 14 (26%) 2 (4%) 16 (29%) Neutropenia 11 (20%) 5 (9%) 16 (29%) Febrile Neutropenia 1 (2%) 0 1 (2%) Lymphopenia 7 (13%) 2 (4%) 9 (16%) Thrombocytopenia 3 (6%) 1 (2%) 4 (7%) Anemia 1 (2%) 1 (2%) 2 (4%) Non-Hematologic Peripheral Neuropathy 5 (9%) 0 5 (9%) Diarrhea 4 (7%) 0 4 (7%) Fatigue 4 (7%) 0 4 (7%) Cough 3 (6%) 0 3 (6%) Rash 2 (4%) 0 2 (4%) Syncope 2 (4%) 0 2 (4%) Disclosures Flinn: Celgene Corporation: Research Funding. Boccia:Incyte Corporation: Honoraria. Berdeja:Array: Research Funding; Curis: Research Funding; Onyx: Research Funding; Abbvie: Research Funding; Acetylon: Research Funding; Novartis: Research Funding; Celgene: Research Funding; Janssen: Research Funding; BMS: Research Funding; MEI: Research Funding; Takeda: Research Funding.

A phase II trial of docetaxel and samarium in patients with bone metastases from castration-refractory prostate cancer (CRPC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5122-5122
Author(s):  
A. Laplanche ◽  
P. Beuzeboc ◽  
J. Lumbroso ◽  
C. Massard ◽  
A. Plantade ◽  
...  
Keyword(s):  
Bone Metastases ◽  
Phase Ii ◽  
Survival Data ◽  
Phase Ii Trial ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Consolidation Therapy ◽  
Pain Level ◽  
Current Standard ◽  
Consolidation Treatment

5122 Background: Most patients (pts) with disseminated CRPC have bone metastases. Docetaxel is the current standard of care in CRPC. We assessed the association of docetaxel and samarium, a radio-pharmaceutical with a high affinity to bone, as consolidation treatment after docetaxel-estramustine. Methods: This is a prospective, bi-center phase II trial. Pts with bone metastases from CRPC received docetaxel 70 mg/m2 day 2 + estramustine 10 mg/Kg/day, day 1–5 (1 cycle/ 3 weeks). Pts with a response or stabilization after 4 cycles were given consolidation therapy: docetaxel 20 mg/m2/week × 6 weeks + samarium 37 MBq/Kg during week 1. Zoledronic acid was routinely used and was stopped 1 month before samarium infusion. A Simon design was used with a target of 39 pts receiving consolidation treatment. Response was defined according to the working group criteria (Bubley, J Clin Oncol 1999). The primary endpoint was progression-free survival (PFS). Results: From 01/04 to 12/05, 43 pts were included in the trial: 31 (72%), 11 (26%) and 1 (3%) achieved a PSA response, stabilization, and progression, respectively. After induction therapy, a pain response (defined as a decrease in pain intensity by at least 2/10 on a pain visual analog scale (VAS) in pts with a baseline pain level = 2/10) was achieved in 60% (18/30) and was confirmed in 69% (20/29) after consolidation therapy. Consolidation docetaxel-samarium was feasible with most pts experiencing a mild (grade 1–2) and rapidly reversible thrombocytopenia at week 5. The 7 months PSA-PFS rate was 48% (33–62%). While PSA relapse eventually occurred in all cases, this strategy resulted in an excellent long-term control of pain, with a median pain level on the VAS of 4/10, 1/10, and 0.5/10 at baseline, 12, and 18 months, respectively. With a median follow-up of 14 months, the median survival has not been reached and the 1-year survival rate is 71% (55–84%). Conclusions: Combining docetaxel and samarium is feasible and well-tolerated. It yields a major pain improvement that lasts long after consolidation therapy in pts with bone metastases from CRPC. Survival data are promising in this population of symptomatic metastatic CRPC. This approach should be tested in phase III trials. No significant financial relationships to disclose.

An open-label, multicenter phase II trial of sunitinib for patients with chemorefractory metastatic gastric cancer.

2010 ◽  
Vol 28 (15_suppl) ◽  
pp. e14503-e14503 ◽  
Author(s):  
M. H. Moehler ◽  
J. T. Hartmann ◽  
F. Lordick ◽  
S. Al-Batran ◽  
P. Reimer ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Metastatic Gastric Cancer ◽  
Open Label ◽  
Multicenter Phase
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