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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267696
• Other study ID #: OSU-05070
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2005
• Last updated: April 28, 2015
• Start date: November 2005
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• Bevacizumab
Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
• Gemcitabine
A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
• Carboplatin

Locations

Country	Name	City	State
United States	The Ohio State University & James Cancer Hospital	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	Eli Lilly and Company, Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	up to 6 months	No
Secondary	Overall Survival for Patients Treated With the Regimen.	The period of time from study entry until disease progression or date of last contact.	To progression of Disease	No

External Links

•   Jamesline