Bortezomib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00052689|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Duct Cell Adenocarcinoma of the Pancreas Stage IV Pancreatic Cancer||Drug: bortezomib Drug: gemcitabine hydrochloride||Phase 2|
I. Compare the objective response rate in previously untreated patients with metastatic pancreatic adenocarcinoma treated with bortezomib with or without gemcitabine.
II. Compare the toxicity of these regimens in these patients. III. Compare the progression-free, 6-month, and overall survival of patients treated with these regimens.
IV. Compare the change in overall quality of life (QOL) and in subcomponents of QOL of patients after treatment with 2 consecutive courses of these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1of 2 treatment arms.
ARM I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients with progressive disease crossover to arm II.
ARM II: Patients receive bortezomib as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.
Courses in both arms repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life (QOL) is assessed at baseline and before courses 2 and 4. Patients who crossover to arm II from arm I complete QOL questionnaires before the first 2 courses of arm II therapy.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Trial of PS-341 and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma|
|Study Start Date :||December 2002|
|Primary Completion Date :||October 2007|
Experimental: Arm I
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients with progressive disease crossover to arm II.
Experimental: Arm II
Patients receive bortezomib as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.
Given IVDrug: gemcitabine hydrochloride
- Confirmed tumor response (CR, PR) rate in 2 consecutive courses within 6 months (Arm I) [ Time Frame: Up to 6 months ]An evaluable patient will be classified as a treatment 'success' if they have a confirmed tumor response (CR, PR). The proportion of successes will be estimated by the total number of evaluable patients. 95% confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.
- Proportion of patients alive at 6 months (Arm II) [ Time Frame: At 6 months ]An evaluable patient will be classified a treatment 'success' if they are alive at 6 months. The proportion of successes will be estimated by the total number of evaluable patients. 95% confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.
- Survival time [ Time Frame: Time from randomization to death due to any cause, assessed up to 5 years ]The distribution of survival time will be estimated using the method of Kaplan-Meier.
- Time to disease progression [ Time Frame: Time from randomization to documentation of disease progression, assessed up to 5 years ]The distribution of time to progression will be estimated using the method of Kaplan-Meier.
- Time to treatment failure [ Time Frame: Time from the date of randomization to the date at which the patient is removed from the treatment due to progression, toxicity, or refusal, assessed up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052689
|United States, Minnesota|
|North Central Cancer Treatment Group|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Steven Alberts||North Central Cancer Treatment Group|