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

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
Larry Copeland, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00267696
First received: December 19, 2005
Last updated: November 5, 2013
Last verified: November 2013
  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
Peritoneal Cancer
Drug: Bevacizumab
Drug: Gemcitabine
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: 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:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

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 ]
    The period of time from study entry until disease progression or date of last contact.


Enrollment: 45
Study Start Date: November 2005
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 administred on day 1 and day 15 of a 28 day cycle
Drug: Carboplatin

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
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, see Learn About Clinical Studies.

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 Comprehensive Cancer Center
Genentech, Inc.
Eli Lilly and Company
Investigators
Principal Investigator: Larry J. Copeland, MD Professor & Chair Department of Obstetrics & Gynecology and Division of Gynecologic Oncology
  More Information

Additional Information:
No publications provided

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
Study First Received: December 19, 2005
Last Updated: November 5, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Bevacizumab
Carboplatin
Gemcitabine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Growth Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014