We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00267696
Recruitment Status : Completed
First Posted : December 21, 2005
Results First Posted : April 30, 2015
Last Update Posted : April 30, 2015
Genentech, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
Larry Copeland, Ohio State University Comprehensive Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Drug: Bevacizumab Drug: Gemcitabine Drug: Carboplatin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : November 2005
Primary Completion Date : September 2013
Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: Gemcitabine/carboplatin/bevacizumab
A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Drug: Bevacizumab
Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Other Name: Avastin®
Drug: Gemcitabine
A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
Drug: Carboplatin

Primary Outcome Measures :
  1. 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: up to 6 months ]
    Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation.

Secondary Outcome Measures :
  1. Overall Survival for Patients Treated With the Regimen. [ Time Frame: To progression of Disease ]
    The period of time from study entry until disease progression or date of last contact.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267696

United States, Ohio
The Ohio State University & James Cancer Hospital
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Genentech, Inc.
Eli Lilly and Company
Principal Investigator: Larry J. Copeland, MD Professor & Chair Department of Obstetrics & Gynecology and Division of Gynecologic Oncology

Additional Information:
Responsible Party: Larry Copeland, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00267696     History of Changes
Other Study ID Numbers: OSU-05070
First Posted: December 21, 2005    Key Record Dates
Results First Posted: April 30, 2015
Last Update Posted: April 30, 2015
Last Verified: April 2015

Keywords provided by Larry Copeland, Ohio State University Comprehensive Cancer Center:
ovarian cancer
platinum sensitive cancer
fallopian tube cancer
peritoneal cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors