Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer - Full Text View

Sponsor:	Ohio State University
Collaborators:	Genentech Eli Lilly and Company
Information provided by (Responsible Party):	Larry Copeland, Ohio State University
ClinicalTrials.gov Identifier:	NCT00267696

Purpose

The purpose of this study is to test the effectiveness, safety and tolerability of the drug combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal cancer.

Condition	Intervention	Phase
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer	Drug: Bevacizumab (drug), Gemcitabine (drug) & Carboplatin (drug)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Gemcitabine/Carboplatin/Bevacizumab in Platinum Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin Gemcitabine Gemcitabine hydrochloride Bevacizumab

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:

Determine the antitumor activity of gemcitabine/carboplatin/bevacizumab regimen as measured by the probability of surviving progression-free for at least 6 months or responding. [ Time Frame: To progression of disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free survival and overall survival for patients treated with the regimen. [ Time Frame: To progression of Disease ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	November 2005
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Bevacizumab(Avastin)=10mg/kg, Carboplatin AUC3, Gemcitabine 1000mg/m2 DAy 1 and Day 15 every 4 weeks.

Detailed Description:

In this study participants will receive the drug combination gemcitabine/carboplatin and bevacizumab once every two weeks. As long as there is evidence that the tumor is not growing and the participant is not experiencing any unacceptable side effects, participation can continue up to 2 years. The study is being done to find the effectiveness, safety and tolerability of this combination of chemotherapy drugs. Bevacizumab affects the growth of new blood vessels in the body. It is part of this study to see if stopping the growth of new blood vessels in the body will help stop the growth and the spread of cancer. The other two chemotherapy drugs, gemcitabine and carboplatin, are currently being used together for the treatment of ovarian cancer.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cancer of the ovaries, fallopian tube or abdominal lining has come back after more than 6 months from the last platinum based chemotherapy treatment.
Disease must be detected by CT or CA125 level must be elevated or cancerous ascites must be present.
History of at least one therapy of platinum based chemotherapy.

Exclusion Criteria:

Participation in another experimental drug study
Heart disease or high blood pressure
History of a stroke within the past 6 months
Vascular disease, or bleeding problems
Brain cancer
Major Surgical Procedure within 28 days prior to start date
Minor surgical procedures within 7 days prior to start date
Pregnant or lactating
Abdominal or bowel problems like bleeding
History of abdominal fistula, GI perforation or Intra-abdominal abscess
Serious, non-healing wound, ulcer or bone fracture
Acute hepatitis
Active infections requiring antibiotics
Inability to comply with study or follow up procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267696

Locations

United States, Ohio
The Ohio State University & James Cancer Hospital
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University

Genentech

Eli Lilly and Company

Investigators

Principal Investigator:

Larry J. Copeland, MD

Professor & Chair Department of Obstetrics & Gynecology and Division of Gynecologic Oncology

More Information

No publications provided

Responsible Party:	Larry Copeland, Professor, Ohio State University
ClinicalTrials.gov Identifier:	NCT00267696 History of Changes
Other Study ID Numbers:	2005CO073
Study First Received:	December 19, 2005
Last Updated:	November 1, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ohio State University:

ovarian cancer
platinum sensitive cancer
fallopian tube cancer
primary peritoneal cancer

Additional relevant MeSH terms:

Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms

Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Gemcitabine
Bevacizumab
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012