Gemcitabine Hydrochloride With or Without Bevacizumab in Treating Patients Who Are Undergoing Surgery for Pancreatic Cancer

NCT ID: NCT00253526

Last Updated: 2015-04-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

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. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells an help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine hydrochloride together with bevacizumab after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying gemcitabine hydrochloride and bevacizumab to see how well they work compared to gemcitabine hydrochloride alone in treating patients who are undergoing surgery for pancreatic cancer.

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 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.

Conditions

Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage I Pancreatic Cancer; Stage II Pancreatic Cancer; Stage III Pancreatic Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

bevacizumab

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

anti-cytokine therapy

Intervention Type: PROCEDURE

antiangiogenesis therapy

Intervention Type: PROCEDURE

antibody therapy

Intervention Type: PROCEDURE

biological therapy

Intervention Type: PROCEDURE

chemotherapy

Intervention Type: PROCEDURE

conventional surgery

Intervention Type: PROCEDURE

growth factor antagonist therapy

Intervention Type: PROCEDURE

monoclonal antibody therapy

Intervention Type: PROCEDURE

surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Richard E. Royal, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Other Identifiers

NCI-05-C-0158

Identifier Type: -

Identifier Source: secondary_id

NCI-P6503

Identifier Type: -

Identifier Source: secondary_id

CDR0000448825

Identifier Type: -

Identifier Source: org_study_id

NCT00158392

Identifier Type: -

Identifier Source: nct_alias