Status:
WITHDRAWN
Gemcitabine Hydrochloride With or Without Bevacizumab in Treating Patients Who Are Undergoing Surgery for Pancreatic Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoc...
Detailed Description
OBJECTIVES: Primary * Compare the disease-free interval in patients with adenocarcinoma of the pancreas treated with surgical resection followed by adjuvant gemcitabine hydrochloride with vs without...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- No evidence of distant metastasis on laparoscopy
- No superior mesenteric artery or thrombosed superior mesenteric vein involvement
- Superior mesenteric vein or portal vein involvement allowed
- Evidence of a pancreatic mass by radiographic or endoscopic examination
- PATIENT CHARACTERISTICS:
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- WBC ≥ 2,500/mm\^3
- Absolute neutrophil count ≥ 1,250/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Hepatitis B surface antigen negative
- Hepatitis C virus negative
- No history of hepatic cirrhosis
- Renal
- Creatinine ≤ 2.0 mg/dL
- Proteinuria negative or trace by urinalysis OR
- Protein \< 1 g on 24 hr urine collection
- No active gross hematuria
- Cardiovascular
- No severe congestive heart failure
- No active ischemic heart disease
- No ischemic changes on a cardiac thallium stress test
- No uncontrolled hypertension (i.e., blood pressure ≤ 150/100 mm Hg despite antihypertensive therapy)
- No active coagulation disorder
- Pulmonary
- No active gross hemoptysis
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during the adjuvant therapy part of trial
- HIV negative
- No active infection
- No wound healing problem from recent invasive procedure
- No significant history of medical illness that would preclude patient from undergoing an operative procedure
- No other malignancy requiring systemic therapy
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Recovered from prior immunotherapy for pancreatic cancer
- No prior bevacizumab
- Chemotherapy
- Recovered from prior chemotherapy for pancreatic cancer
- No prior gemcitabine hydrochloride
- Endocrine therapy
- Recovered from prior hormonal therapy for pancreatic cancer
- Radiotherapy
- Recovered from prior radiotherapy for pancreatic cancer
- No prior radiotherapy to the pancreas
- Surgery
- No prior definitive resection of the primary pancreatic tumor
- Prior surgery, other than resection of the primary tumor, allowed
- Other
- More than 3 weeks since prior systemic therapy for this cancer
- No concurrent therapeutic anticoagulation causing elevated PT or PTT
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00253526
Last Update
April 28 2015
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