A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Outcome unknown
Record metadata
- Phase
- Phase 3
- Status
- Completed
- Start
- 2005-07
- End
- 2008-10
- Enrollment
- 607
- Sites
- 101
- Sponsor class
- INDUSTRY
- Results posted
- 2014-08-13
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Source text
Brief summary · public domain (ClinicalTrials.gov) · T1
This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: bevacizumab [Avastin]. Intervenous repeating dose
Arm · public domain (ClinicalTrials.gov) · T1
1 (experimental):
Primary outcome · public domain (ClinicalTrials.gov) · T1
Duration of Overall Survival - Percentage of Participants With an Event. Duration of overall survival (OS) was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Time frame: Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized.
Primary outcome · public domain (ClinicalTrials.gov) · T1
Duration of Overall Survival - Time to Event. Duration of OS was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median duration of survival was estimated using the Kaplan-Meier method. Time frame: Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Clinical Benefit Response (CBR). Time frame: Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Progression-Free Survival (PFS) - Percentage of Participants With an Event. Time frame: Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Progression-Free Survival (PFS) - Time to Event. Time frame: Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment. Time frame: Baseline and Week 8.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib. Time frame: Weeks 1, 3, 5, 7, and 9.
Eligibility · public domain (ClinicalTrials.gov) · T1
Inclusion Criteria: * adult patients, \>=18 years of age; * metastatic pancreatic cancer (adenocarcinoma); * good liver, kidney, and bone marrow function. Exclusion Criteria: * previous systemic treatment for metastatic pancreatic cancer; * pregnant or lactating females; * fertile men, or women of childbearing potential, not using adequate contraception; * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start; * current or recent treatment (within 30 days prior to starting study treatment) with another investigational drug, or participation in another investigational study.
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 607 participants (actual).