Gemcitabine and Bevacizumab in Treating Patients With Pancreatic Cancer That Has Been Completely Removed By Surgery

NCT00410774 | Terminated Phase 1 DMC

• 3 other identifiers: CDR0000517330UCSF-06451UCSF-H12191-28980-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, 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 and 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 and bevacizumab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase I/II trial is studying the side effects of gemcitabine and bevacizumab and to see how well they work in treating patients with pancreatic cancer that has been completely removed by surgery.

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic cancer; stage I pancreatic cancer; adenocarcinoma of the pancreas; stage II pancreatic cancer

Outcome Measures

Primary Outcomes (2)

• Safety of gemcitabine when administered with bevacizumab as assessed by NCI CTCAE v3.0

• Disease-free survival rate at 1 year

Secondary Outcomes (3)

• Overall survival rate at 1 and 2 years

• Median disease-free survival rate at 1 and 2 years

• Median overall survival rate at 1 and 2 years

Interventions

bevacizumab BIOLOGICAL

gemcitabine hydrochloride DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the pancreas * Completely resected disease * Underwent 1 of the following procedures 3-8 weeks ago: * Standard pancreaticoduodenectomy (for tumors of the pancreatic head) * Distal pancreatectomy (for tumors of the pancreatic tail) * No grossly positive surgical margins * Positive microscopic margins allowed * Nonmeasurable disease * No known CNS disease PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study therapy * CA 19-9 ≤ 2.5 times upper limit of normal (ULN) * Absolute neutrophil count ≥ 1,500/mm³ * Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed) * Platelet count ≥ 100,000/mm³ * INR ≤ 1.5 (except in patients receiving full-dose warfarin) * Bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 2.5 times ULN * Creatinine ≤ 2.0 mg/dL * No clinically significant impairment of renal function * No postoperative complications, including any of the following: * Wound dehiscence or infection * Intra-abdominal abscess * Pancreatic or biliary leak or fistula * Grade 3 or 4 delayed hemorrhage (occurring \> 5 days postoperatively) * Bowel perforation * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abcess within the past 6 months * No history of major psychiatric disorder or other chronic medical illness that, in the opinion of the treating physician, contraindicates use of the study drugs or renders the patient at high risk of treatment-related complications * No other cancer within the past 5 years except basal cell or squamous cell skin cancer * No history of serious systemic disease, including any of the following: * Myocardial infarction or unstable angina within the past 12 months * New York Heart Association class II-IV congestive heart failure * Unstable symptomatic arrhythmia requiring medication * Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed * No history of stroke or transient ischemic attack * No symptomatic peripheral vascular disease * No significant vascular disease (e.g., aortic aneurysm, aortic dissection) * No inadequately controlled hypertension (i.e., blood pressure \> 150/100 mm Hg on antihypertensive medication) * No prior hypertensive crisis or hypertensive encephalopathy * No proteinuria (defined as urine protein:creatinine ratio ≥ 1.0 OR proteinuria ≥ 2+ by dipstick urinalysis OR protein \> 1 g by 24-hour urine collection) * No serious, nonhealing wound or ulcer * No evidence of bleeding diathesis or coagulopathy * No significant traumatic injury within the past 28 days PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy or radiotherapy for pancreatic cancer * No prior systemic or investigational therapy for pancreatic cancer * No major surgical procedure (except for resection of pancreatic cancer) or open biopsy within the past 28 days * No fine-needle aspiration or core biopsy within the past 7 days * No anticipated need for a major surgical procedure during study treatment * No concurrent newly prescribed nonsteroidal anti-inflammatory drugs (NSAIDs) * Concurrent chronic-dose NSAIDs for analgesia are allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Bevacizumab; Gemcitabine; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Andrew Ko, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2006
• First Posted: December 13, 2006
• Study Start: July 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: September 17, 2012

Record last verified: 2012-09

Locations

US (1)