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A Phase II Study of Gemcitabine/Carboplatin/Bevacizumab in Platinum Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients.


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Thank you

Trial Information

A Phase II Study of Gemcitabine/Carboplatin/Bevacizumab in Platinum Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

To progression of disease

Safety Issue:

No

Principal Investigator

Larry J. Copeland, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Food and Drug Administration

Study ID:

2005CO073

NCT ID:

NCT00267696

Start Date:

November 2005

Completion Date:

December 2013

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • ovarian cancer
  • platinum sensitive cancer
  • fallopian tube cancer
  • primary peritoneal cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location
The Ohio State University & James Cancer Hospital Columbus, Ohio  43210