Status:
COMPLETED
Gemcitabine With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This randomized phase III trial is studying gemcitabine and bevacizumab to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic pancreatic canc...
Detailed Description
PRIMARY OBJECTIVES: I. To determine if combination chemotherapy with gemcitabine and bevacizumab achieves superior survival compared to gemcitabine and placebo in patients with previously untreated a...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologic or cytologic documentation of adenocarcinoma of the pancreas; documentation of disease extent by CT scan is required; radiologically measurable disease is not required; patients with documented invasion of adjacent organs (e.g., duodenum, stomach) by CT scan are not eligible
- No prior chemotherapy for metastatic disease
- If the patient received adjuvant therapy, it must have been completed at least 4 weeks prior to enrollment on this study; the patient must have recovered from all treatment related toxicities and must have evidence of disease progression following adjuvant treatment
- Prior radiation therapy, with or without a radiosensitizing dose of fluoropyrimidines, is allowed provided the patient has disease outside of the radiation port; at least 4 weeks must have elapsed from completion of the radiation therapy and all signs of toxicity must have resolved
- No prior treatment with gemcitabine or bevacizumab in the adjuvant or metastatic setting
- No current or recent (within 1 month) use of a thrombolytic agent
- Patients may not have had prior therapy with other VEGF inhibitors
- No recent invasive surgical procedures; this includes:
- Major surgical procedure (e.g. exploratory laparotomy or laparoscopy), open biopsy, or significant traumatic injury within 28 days prior to registration
- Fine needle aspirations or venous access device within 7 days prior to registration
- Anticipation of need for major surgical procedures during the course of the study
- No clinically significant cardiovascular disease; this includes:
- Uncontrolled hypertension (blood pressure \> 150/90 on medication)
- New York Heart Association grade II or greater congestive heart failure
- Serious cardiac arrhythmia requiring medication
- No recent (within 6 months) arterial thrombotic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are also ineligible
- No evidence of CNS disease, including primary brain tumor, or any brain metastasis
- No serious or non-healing wound, ulcer or bone fracture
- No serious active infection (viral, fungal bacterial); no infection requiring parenteral antibiotics at time of registration
- Patients with known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies are not eligible
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered; patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse
- Women must be non-pregnant and non-breast feeding
- ECOG Performance status of 0, 1 or 2
- Granulocytes ≥ 1,500/μl
- Platelet count ≥ 100,000/μl
- Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min
- Total bilirubin ≤ 1 x upper limit of normal
- SGOT(AST) ≤ 2.5 x upper limit of normal
- PT INR =\< 1.5, unless patient is on full dose warfarin
- Urine protein; for ≥ 1+ proteinuria, 24 hour urine collection must demonstrate \< 1 gm of protein/24 hours
- Required diagnostic procedures:
- CT of the abdomen
- Chest x-ray
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
590 Patients enrolled
Trial Details
Trial ID
NCT00088894
Start Date
June 1 2004
Last Update
June 5 2013
Active Locations (1)
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1
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606