Bevacizumab Study With Carboplatin & Paclitaxel in Ovarian, Fallopian Tube or Primary Peritoneal Cancer
This study has been terminated.
(Did not meet accrual goals.)
Sponsor:
University of Connecticut Health Center
Collaborator:
Genentech
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00408070
First received: December 5, 2006
Last updated: November 16, 2010
Last verified: November 2010
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Purpose
The primary objective is to determine whether the addition of bevacizumab to a regimen of carboplatin plus paclitaxel significantly improves Progression Free Survival (PFS) for patient with Stage III suboptimally cytoreduced or Stage IV ovarian, primary peritoneal or fallopian tube carcinomas.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Stage 3 Cancer Stage 4 Cancer |
Drug: Bevacizumab Drug: Carboplatin Drug: Paclitaxel |
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: | Phase 2 Study of Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma |
Resource links provided by NLM:
Further study details as provided by University of Connecticut Health Center:
Primary Outcome Measures:
- Progression Free Survival Rate at 9 Months [ Time Frame: 9 months ] [ Designated as safety issue: No ]This Outcome is measuring the number of particpants who have survived.
Secondary Outcome Measures:
- Response to Treatment (Clinical/Pathological) [ Time Frame: not assessed; study terminated early ] [ Designated as safety issue: No ]
- Rate of Decline of CA-125 [ Time Frame: not assessed; study terminated early ] [ Designated as safety issue: No ]
- To Determine the Degree and Type of Toxicity of This Combined Regimen [ Time Frame: weekly ] [ Designated as safety issue: No ]
- Determine Tolerability to 12 Months (q 3 Weeks) of Bevacizumab Maintenance Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 5 |
| Study Start Date: | October 2006 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I
This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.
|
Drug: Bevacizumab
cycle 2 (6 cycles re-evaluated and follow up)
Other Name: Avastin (brand name)
Drug: Carboplatin
cycle #1 and continuous through entire regimen; treated every 3 weeks
Other Name: Paraplatin
Drug: Paclitaxel
cycle #1 and continuous through entire regimen; treated every 3 weeks
Other Name: Taxol (brand name)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- diagnosis of primary peritoneal carcinoma, fallopian tube epithelial ovarian carcinoma,
- stage III suboptimal surgery or biopsy,
- stage IV disease
- no prior chemotherapy
Exclusion Criteria:
- unstable heart conditions
- high blood pressure
- vascular disorders
- bleeding problems
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408070
Locations
| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030 | |
Sponsors and Collaborators
University of Connecticut Health Center
Genentech
Investigators
| Principal Investigator: | Carolyn Runowicz, MD | University of Connecticut Health Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Carolyn Runowicz, MD, Univ. of CT Health Center |
| ClinicalTrials.gov Identifier: | NCT00408070 History of Changes |
| Other Study ID Numbers: | AVF 3696s, IRB 06-337-1 |
| Study First Received: | December 5, 2006 |
| Results First Received: | October 14, 2010 |
| Last Updated: | November 16, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Connecticut Health Center:
|
ovarian cancer fallopian tube cancer 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 Bevacizumab Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013