Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Larry Copeland
Collaborators:
Genentech
Eli Lilly and Company
Information provided by (Responsible Party):
Larry Copeland, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00267696
First received: December 19, 2005
Last updated: July 20, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer |
Drug: Bevacizumab (drug), Gemcitabine (drug) & Carboplatin (drug) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Gemcitabine/Carboplatin/Bevacizumab in Platinum Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients. |
Resource links provided by NLM:
Further study details as provided by Ohio State University:
Primary Outcome Measures:
- 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: To progression of disease ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression free survival and overall survival for patients treated with the regimen. [ Time Frame: To progression of Disease ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Bevacizumab (drug), Gemcitabine (drug) & Carboplatin (drug)
Bevacizumab(Avastin)=10mg/kg, Carboplatin AUC3, Gemcitabine 1000mg/m2 DAy 1 and Day 15 every 4 weeks.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267696
Locations
| United States, Ohio | |
| The Ohio State University & James Cancer Hospital | |
| Columbus, Ohio, United States, 43210 | |
Sponsors and Collaborators
Larry Copeland
Genentech
Eli Lilly and Company
Investigators
| Principal Investigator: | Larry J. Copeland, MD | Professor & Chair Department of Obstetrics & Gynecology and Division of Gynecologic Oncology |
More Information
No publications provided
| Responsible Party: | Larry Copeland, Professor, The Ohio State University |
| ClinicalTrials.gov Identifier: | NCT00267696 History of Changes |
| Other Study ID Numbers: | 2005CO073 |
| Study First Received: | December 19, 2005 |
| Last Updated: | July 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Ohio State University:
|
ovarian cancer platinum sensitive cancer fallopian tube cancer primary peritoneal cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Gemcitabine Bevacizumab Carboplatin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013