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

NCT00267696 | Completed Phase 2 Results DMC

• 1 other identifier: OSU-05070
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Keywords

ovarian cancer; platinum sensitive cancer; fallopian tube cancer; peritoneal cancer

Outcome Measures

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.

  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

Secondary Outcomes (1)

• Overall Survival for Patients Treated With the Regimen.

  To progression of Disease

Study Arms (1)

Gemcitabine/carboplatin/bevacizumab

EXPERIMENTAL

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; Drug: Gemcitabine; Drug: Carboplatin

Interventions

Bevacizumab DRUG

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

Also known as: Avastin®

Gemcitabine/carboplatin/bevacizumab

Gemcitabine DRUG

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

Gemcitabine/carboplatin/bevacizumab

Carboplatin DRUG

Gemcitabine/carboplatin/bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Genentech, Inc.: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

The Ohio State University & James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

Related 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.2008.08.011. Epub 2008 Sep 30.

  PMID: 18829088 RESULT

Related Links

• Jamesline

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Bevacizumab; Gemcitabine; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Larry Copeland, MD
• Organization: The Ohio State University Comprehensive Cancer Center

Larry.Copeland@osumc.edu

614-293-8697

Study Officials

• Larry J. Copeland, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2005
• First Posted: December 21, 2005
• Study Start: November 1, 2005
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 30, 2015
• Results First Posted: April 30, 2015

Record last verified: 2015-04

Locations

US (1)