Completed

A Randomized Phase III Trial Of Gemcitabine Plus Bevacizumab (NSC#704865 IND#7621) Versus Gemcitabine Plus Placebo In Patients With Advanced Pancreatic Cancer

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What is being tested

gemcitabine hydrochloride

+ bevacizumab

+ laboratory biomarker analysis

DrugBiologicalOther
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Endocrine System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. To determine if combination chemotherapy with gemcitabine and bevacizumab achieves superior survival compared to gemcitabine and placebo in patients with previously untreated advanced pancreatic cancer. SECONDARY OBJECTIVES: I. To compare the objective response rates, duration of response, progression free survival, and toxicity of these two regimens in patients with advanced pancreatic cancer. II. To measure baseline levels of VEGF and correlate with treatment outcome. III. To measure baseline and on treatment levels of additional growth factors that may be co- or counter- regulated with VEGF and correlate with response to treatment. IV. To measure baseline and on treatment levels of coagulation and endothelial cell activation markers that may predict for thrombotic or bleeding risks related to treatment. V. To generate protein expression profiles using a MALDI-TOF based platform from serum samples. To analyze and compare protein expression profiles to elucidate ion peaks that differentiate patients who respond to therapy from patients who do not respond. To identify proteins responsible for the differentially expressed ion peaks. To develop quantitative assays for each of these proteins. VI. To assess any differences in overall survival within the treatment arm (gemcitabine + bevacizumab), between the two VEGF genotypic groups: Group 1 denoted by individuals with CT or TT genotypes and Group 2 consisting of individuals with CC genotypes. VII. To conduct an exploratory analysis of gene-toxicity, gene-response, and gene-survival relationships for the various polymorphisms described in the genes implicated in gemcitabine pharmacology (CDA, DCK, DCTD, SLC29A1, SLC28A1, SLC29A2). An exploratory quantitative interaction between the genotypes (group 1 or 2) and the treatment arms (gemcitabine + bevacizumab or gemcitabine + placebo) in predicting overall survival will also be evaluated. VIII. To identify specific SNPs and genetic variation that are associated with differences among patients in the risk of toxicity. IX. To compare the effects of gemcitabine + bevacizumab versus gemcitabine + placebo on resource utilization, cost, and utilities, and if applicable, to make estimates of marginal cost-utility. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to ECOG performance status (0-1 vs 2), disease extent (metastatic vs locally advanced), and prior radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Arm II: Patients receive gemcitabine IV as in arm I and placebo IV over 30-90 minutes on days 1 and 15. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 590 patients (295 per treatment arm) will be accrued for this study within 26.8 months.

Official TitleA Randomized Phase III Trial Of Gemcitabine Plus Bevacizumab (NSC#704865 IND#7621) Versus Gemcitabine Plus Placebo In Patients With Advanced Pancreatic Cancer 
NCT00088894
Principal SponsorNational Cancer Institute (NCI)
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

590 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasmsNeoplasms by SitePancreatic DiseasesPancreatic Neoplasms

Criteria

Inclusion Criteria: * Histologic or cytologic documentation of adenocarcinoma of the pancreas; documentation of disease extent by CT scan is required; radiologically measurable disease is not required; patients with documented invasion of adjacent organs (e.g., duodenum, stomach) by CT scan are not eligible * No prior chemotherapy for metastatic disease * If the patient received adjuvant therapy, it must have been completed at least 4 weeks prior to enrollment on this study; the patient must have recovered from all treatment related toxicities and must have evidence of disease progression following adjuvant treatment * Prior radiation therapy, with or without a radiosensitizing dose of fluoropyrimidines, is allowed provided the patient has disease outside of the radiation port; at least 4 weeks must have elapsed from completion of the radiation therapy and all signs of toxicity must have resolved * No prior treatment with gemcitabine or bevacizumab in the adjuvant or metastatic setting * No current or recent (within 1 month) use of a thrombolytic agent * Patients may not have had prior therapy with other VEGF inhibitors * No recent invasive surgical procedures; this includes: * Major surgical procedure (e.g. exploratory laparotomy or laparoscopy), open biopsy, or significant traumatic injury within 28 days prior to registration * Fine needle aspirations or venous access device within 7 days prior to registration * Anticipation of need for major surgical procedures during the course of the study * No clinically significant cardiovascular disease; this includes: * Uncontrolled hypertension (blood pressure \> 150/90 on medication) * New York Heart Association grade II or greater congestive heart failure * Serious cardiac arrhythmia requiring medication * No recent (within 6 months) arterial thrombotic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are also ineligible * No evidence of CNS disease, including primary brain tumor, or any brain metastasis * No serious or non-healing wound, ulcer or bone fracture * No serious active infection (viral, fungal bacterial); no infection requiring parenteral antibiotics at time of registration * Patients with known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies are not eligible * Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered; patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse * Women must be non-pregnant and non-breast feeding * ECOG Performance status of 0, 1 or 2 * Granulocytes ≥ 1,500/μl * Platelet count ≥ 100,000/μl * Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min * Total bilirubin ≤ 1 x upper limit of normal * SGOT(AST) ≤ 2.5 x upper limit of normal * PT INR =\< 1.5, unless patient is on full dose warfarin * Urine protein; for ≥ 1+ proteinuria, 24 hour urine collection must demonstrate \< 1 gm of protein/24 hours * Required diagnostic procedures: * CT of the abdomen * Chest x-ray

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15.

Group II

Active Comparator
Patients receive gemcitabine IV as in arm I and placebo IV over 30-90 minutes on days 1 and 15.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Cancer and Leukemia Group B

Chicago, United StatesSee the location
CompletedOne Study Center