Phase II Randomized Study of Surgical Resection and Adjuvant Gemcitabine Hydrochloride With Versus Without Bevacizumab in Patients With Adenocarcinoma of the Pancreas
18 Years
N/A
Both
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage I Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer
Trial Information
Phase II Randomized Study of Surgical Resection and Adjuvant Gemcitabine Hydrochloride With Versus Without Bevacizumab in Patients With Adenocarcinoma of the Pancreas
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 bevacizumab.
Secondary
- Compare overall survival in patients treated with these regimens.
- Evaluate tumor gene expression profiles and levels of tumor angiogenesis markers to
establish prognostic indicators for response in patients treated with these regimens.
OUTLINE: This is a randomized, controlled study.
All patients undergo surgical resection for the pancreatic tumor. Within 4-8 weeks after
surgery, patients are stratified according to projected 2-year survival (≤ 5% vs > 5% and ≤
33% vs > 33%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on days 1, 8, and
15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28
days for 6 courses. Patients then receive bevacizumab IV alone every 2 weeks for up to
2 years in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes on days 1, 8,
and 15. Treatment repeats every 28 days for 6 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Richard E. Royal, MD, FACS
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
CDR0000448825
NCT ID:
NCT00253526
Start Date:
Completion Date:
Related Keywords:
- Adenocarcinoma of the Pancreas
- Recurrent Pancreatic Cancer
- Stage I Pancreatic Cancer
- Stage II Pancreatic Cancer
- Stage III Pancreatic Cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Pancreatic Neoplasms
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