scholarly journals Clinical Benefit Response in Pancreatic Cancer Trials Revisited

2014 ◽  
Vol 37 (1) ◽  
pp. 1-1 ◽  
Author(s):  
Jürg Bernhard ◽  
Daniel Dietrich ◽  
Bengt Glimelius ◽  
György Bodoky ◽  
Werner Scheithauere ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Benefit ◽  
Clinical Benefit Response ◽  
Cancer Trials

Gemcitabine and Infusional 5-Fluorouracil in Advanced Pancreatic Cancer: A Clinical Benefit Response-Oriented Phase II Study

2003 ◽  
Vol 35 (3) ◽  
pp. 213-217
Author(s):  
Jung Hye Choi ◽  
Myung Ju Ahn ◽  
Seock Ah Im ◽  
Bong Seog Kim ◽  
Ho Suk Oh ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Phase Ii ◽  
Clinical Benefit ◽  
Phase Ii Study ◽  
Advanced Pancreatic Cancer ◽  
Clinical Benefit Response ◽  
Oriented Phase

Phase II Study of Oral Capecitabine in Patients With Advanced or Metastatic Pancreatic Cancer

2002 ◽  
Vol 20 (1) ◽  
pp. 160-164 ◽  
Author(s):  
Thomas H. Cartwright ◽  
Allen Cohn ◽  
Jerry A. Varkey ◽  
Yin-Miao Chen ◽  
Ted P. Szatrowski ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Benefit ◽  
Objective Response ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
Treatment Modalities ◽  
Intermittent Therapy ◽  
Oral Capecitabine ◽  
Clinical Benefit Response

PURPOSE: To determine the safety and efficacy of capecitabine (Xeloda; Roche Laboratories, Nutley, NJ) in patients with metastatic or unresectable, locally advanced pancreatic cancer. PATIENTS AND METHODS: Forty-two patients were treated with oral capecitabine 1,250 mg/m2 administered twice daily (2,500 mg/m2/d) as intermittent therapy in 3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment. Tumor lesions were assessed by computed tomography scan or physical examination at 6-week intervals (after every two cycles). Adverse events were monitored continuously during treatment and for 28 days after the last dose of study drug. RESULTS: Ten (24%) of 42 patients experienced a clinical benefit response (95% confidence interval [CI], 12.1% to 39.5%) as evidenced by improvement in pain intensity, analgesic consumption, and/or Karnofsky performance status. Three (7.3%) of the 41 patients with measurable disease had an objective response (partial). The median time to objective response was 85 days (range, 47 to 91 days) and duration of response was 208, 260, and 566 days for the three responding patients. One patient with nonmeasurable but assessable disease had improved residual disease with a positive clinical benefit response, for a total of four responses among the 42 assessable patients, for an overall response rate of 9.5% (90% CI, 3.3% to 20.5%). Capecitabine was generally well tolerated. CONCLUSION: Treatment with capecitabine resulted in clinically significant beneficial effects on tumor-related symptoms and yielded objective response activity in patients with metastatic or locally advanced pancreatic cancer. These results together with its generally tolerable safety profile and the added advantage of oral administration provide the basis for further evaluating capecitabine as a single agent or in combination with other treatment modalities in this patient population.

A pilot phase I/II study of combination chemotherapy with nafamostat mesilate and gemcitabine for unresectable pancreatic cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15600-e15600
Author(s):  
T. Uwagawa ◽  
T. Misawa ◽  
T. Iida ◽  
M. Matsumoto ◽  
T. Gocho ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Combination Chemotherapy ◽  
Clinical Benefit ◽  
Phase 1 ◽  
Reduction Rate ◽  
Oral Morphine ◽  
Nafamostat Mesilate ◽  
Unresectable Pancreatic Cancer ◽  
Clinical Benefit Response

e15600 Background: To improve chemoresistance of gemcitabine (GEM) caused by GEM-induced nuclear factor kappa B (NF- κB) activation, we have conducted combination chemotherapy of GEM with NF-κB inhibitor, nafamostat mesilate (NAM) which is commercially approved as an effective therapeutic agent for disseminated intravascular coagulation, systemic response syndrome, or pancreatitis in Japan for patients with unresectable pancreatic cancer patients through phase 1/2 study. Methods: Study treatment consists of GEM 1,000 mg/m2 on d 8, 15 and 22 plus NAM 2.4∼4.8 mg/kg on d 8, 15 and 22. NAM was administered intra-arterially by continuous regional infusion for 24 hours via an infusion port system one hour before administration of GEM. Overall survival, response rate (RECIST), serum CA19–9 and clinical benefit response (body weight, pain alleviation) were assessed. Results: Between Feb 2007 and Oct 2008, 20 patients with unresectable pancreatic cancer were included in this study. Pts characteristics: male/female: 18/2, median age 63.5 (range 38–79) yrs, median Karnofsky PS 80% (range 70–90%), stage III/IV: 8/12, serum CA19–9 4,662 U/ml (range 88–32,100), baseline visual analogue scale 0–1/2–4/5–7/8–10; 9/4/7/0, baseline analgesic consumption (morphine-equivalent, mg/day) 0/10–100/100>; 10/7/3. The combination of NAM with GEM is well tolerated and MTD has not been reached. The recommended dose was GEM 1,000 mg/m2; NAM 4.8 mg/kg. Overall survival was 8.0 (range 4.7–17) months. CR/PR/NC/PD/not evaluated; 0/3/14/2/1. Serum CA19–9 reduction rate; 89%. Three pts. could become off and 1pt. could reduce oral morphine sulfate, and 5 pts. gained weight. Conclusions: The GEM/NAM regimen is safe, and the clinical data, including overall survival and clinical benefit response, suggest that the initial clinical outcome of this trial has been encouraging. An expanded cohort of the combination chemotherapy is underway. No significant financial relationships to disclose.

Small molecule tyrosine kinase inhibitors and pancreatic cancer—Trials and troubles

2019 ◽  
Vol 56 ◽  
pp. 149-167 ◽  
Author(s):  
Bhaskar Venkata Kameswara Subrahmanya Lakkakula ◽  
Batoul Farran ◽  
Saikrishna Lakkakula ◽  
Sujatha Peela ◽  
Nagendra Sastry Yarla ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Tyrosine Kinase ◽  
Tyrosine Kinase Inhibitors ◽  
Small Molecule ◽  
Kinase Inhibitors ◽  
Cancer Trials

Capecitabine As First-Line Treatment for Patients Older Than 70 Years With Metastatic Colorectal Cancer: An Oncopaz Cooperative Group Study

2005 ◽  
Vol 23 (13) ◽  
pp. 3104-3111 ◽  
Author(s):  
Jaime Feliu ◽  
Pilar Escudero ◽  
Ferrán Llosa ◽  
Matilde Bolaños ◽  
Jose-Manuel Vicent ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Elderly Patients ◽  
Combination Chemotherapy ◽  
Clinical Benefit ◽  
Overall Response Rate ◽  
Advanced Colorectal Cancer ◽  
First Line ◽  
Hand Foot Syndrome ◽  
Clinical Benefit Response ◽  
Grade 3

Purpose To determine the tolerability of capecitabine in elderly patients with advanced colorectal cancer (CRC). Patients and Methods Fifty-one patients with advanced CRC who were ≥ 70 years and considered ineligible for combination chemotherapy received oral capecitabine 1,250 mg/m2 twice daily on days 1 to 14 every 3 weeks. Patients with a creatinine clearance of 30 to 50 mL/min received a dose of 950 mg/m2 twice daily. Results A total of 248 cycles of capecitabine were administered (median, five cycles; range, one to eight cycles). The overall response rate was 24% (95% CI, 15% to 41%), including two complete responses (CR; 4%) and 10 partial responses (PR; 20%). Disease control (CR + PR + stable disease) was achieved in 67% of patients. The median times to disease progression and overall survival were 7 months (95% CI, 6.4 to 9.5 months) and 11 months (95% CI, 8.6 to 13.3 months), respectively. Of the 35 patients evaluated for clinical benefit response, 14 (40%; 95% CI, 24% to 58%) showed clinical benefit. Capecitabine was well tolerated. Treatment-related grade 3 and 4 adverse events were observed in only six patients (12%), and the most common events were diarrhea, hand-foot syndrome, and thrombocytopenia. One patient (2%) had an episode of angina, but no treatment-related deaths were reported. Conclusion Our findings suggest that capecitabine is effective and well tolerated in elderly patients with advanced CRC who are considered ineligible for combination chemotherapy.

14A A design for assessing clinical benefit for patients with advanced pancreatic cancer

1994 ◽  
Vol 15 (3) ◽  
pp. 41
Author(s):  
John S. Andersen ◽  
Howard Burris ◽  
Ephraim Casper ◽  
Michael Clayman ◽  
Mark Green ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Benefit ◽  
Advanced Pancreatic Cancer
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