A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-06-30

Brief Summary

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This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.

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Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine

Group Type EXPERIMENTAL

Volociximab

Intervention Type DRUG

Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.

Gemcitabine

Intervention Type DRUG

Gemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment

Cohort 2

Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine

Group Type EXPERIMENTAL

Volociximab

Intervention Type DRUG

Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.

Gemcitabine

Intervention Type DRUG

Gemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment

Interventions

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Volociximab

Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.

Intervention Type DRUG

Gemcitabine

Gemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, 18 years of age or older.
* Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
* May have received prior immunotherapy (including monoclonal antibodies) or vaccine therapies.
* Measurable disease, according to RECIST criteria.
* Negative pregnancy test (women of childbearing potential only).
* Pretreatment laboratory levels that meet specific criteria.

Exclusion Criteria

* Prior treatment with Volociximab (M200) or inhibitors of α5β1 integrin (antibodies or small molecules) or gemcitabine and other chemotherapeutic regimens.
* Known hypersensitivity to murine proteins or chimeric antibodies or other components of the product.
* Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
* Monoclonal antibody therapy within 4 weeks of the first dose of Volociximab.
* Central Nervous System (CNS) tumor or metastasis.
* History of bleeding disorders within the past year.
* Medical conditions that may be exacerbated by bleeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No