Gemcitabine, Cisplatin, and Bevacizumab in Treating Patients With Metastatic Pancreatic Cancer

NCT00126633 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000437858UCSF-04451GENENTECH-AVF2937s
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, 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 tumor cells by blocking blood flow to the tumor. Giving gemcitabine and cisplatin together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together with bevacizumab works in treating patients with metastatic pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (5)

• Time to progression

• Duration of response

• Overall survival

• Toxicity as measured by NCI CTC version 2.0

• Micrometastases for predicting time to progression and overall survival

Interventions

bevacizumab BIOLOGICAL

cisplatin DRUG

gemcitabine hydrochloride DRUG

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 * Must have documented extrapancreatic metastases * Radiographically measurable disease is not required * Previously untreated disease * No CNS or brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa \[Epogen®\] support allowed) * No evidence of bleeding diathesis or coagulopathy Hepatic * INR ≤ 1.5 (except for patients receiving full-dose warfarin) * Bilirubin ≤ 2.0 mg/dL * AST or ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Renal * Creatinine ≤ 2.0 mg/dL * Urine protein:creatinine ratio ≤ 1 Cardiovascular * No New York Heart Association class II-IV congestive heart failure * No myocardial infarction or stroke within the past 6 months * No uncontrolled hypertension (i.e., blood pressure \> 160/110 mm Hg despite antihypertensive therapy) * No unstable angina * No unstable symptomatic arrhythmia requiring medication * Patients with chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are eligible * No peripheral vascular disease ≥ grade 2 Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study treatment * No significant traumatic injury within the past 28 days * No serious non-healing wound, ulcer, or bone fracture * No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No other serious systemic disease * No history of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * More than 28 days since prior major surgery, or open biopsy * More than 7 days since prior fine needle aspirations or core biopsies * No concurrent major surgery Other * No prior therapy, including systemic or investigational therapy, for locally advanced or metastatic pancreatic cancer * Treatment given in the adjuvant setting (e.g., radiotherapy and/or chemotherapy, given either concurrently or systemically) is not considered prior therapy provided progressive disease occurred \> 6 months after completion of prior treatment * Concurrent continuation of therapeutic doses of warfarin or low-molecular weight heparin allowed for pulmonary embolism, deep vein thrombosis, atrial fibrillation, or other clinical indications provided patients has been on a stable dose for ≥ 28 days with no further clotting or bleeding complications

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 Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Related Publications (1)

• Ko AH, Dito E, Schillinger B, Venook AP, Xu Z, Bergsland EK, Wong D, Scott J, Hwang J, Tempero MA. A phase II study evaluating bevacizumab in combination with fixed-dose rate gemcitabine and low-dose cisplatin for metastatic pancreatic cancer: is an anti-VEGF strategy still applicable? Invest New Drugs. 2008 Oct;26(5):463-71. doi: 10.1007/s10637-008-9127-2. Epub 2008 Apr 1.

  PMID: 18379729 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Bevacizumab; Cisplatin; Gemcitabine

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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Andrew Ko, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2005
• First Posted: August 4, 2005
• Study Start: April 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: October 1, 2008
• Last Updated: September 17, 2012

Record last verified: 2012-09

Locations

US (1)