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Completed

NCT Number: NCT00267696

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.

Other names: Avastin®

Gemcitabine

Drug

A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle

carboplatin

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • Eli Lilly and Company
  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Dec 21, 2005
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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