Clinical trial NCT00267696: Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Official title: A Phase II Study of Gemcitabine/Carboplatin/Bevacizumab in Platinum Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Keywords: ovarian cancer
platinum sensitive cancer
fallopian tube cancer
peritoneal cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Eli Lilly and Company
First posted: 2005-12-21
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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.
timeFrame: up to 6 months
Secondary outcomes:
measure: Overall Survival for Patients Treated With the Regimen.
timeFrame: To progression of Disease
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University & James Cancer Hospital
state: Ohio
Study officials:
affiliation: Professor & Chair Department of Obstetrics & Gynecology and Division of Gynecologic Oncology
name: Larry J. Copeland, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Richardson DL, Backes FJ, Seamon LG, Zanagnolo V, O'Malley DM, Cohn DE, Fowler JM, Copeland LJ. Combination gemcitabine, platinum, and bevacizumab for the treatment of recurrent ovarian cancer. Gynecol Oncol. 2008 Dec;111(3):461-6. doi: 10.1016/j.ygyno.2008.08.011. Epub 2008 Sep 30.