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| Sponsors and Collaborators: |
University of Connecticut Health Center Genentech |
|---|---|
| Information provided by: | University of Connecticut |
| ClinicalTrials.gov Identifier: | NCT00408070 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase 2 Study of Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma |
| Enrollment: | 5 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
I: Experimental
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)
Drug: Carboplatin
cycle #1 and continuous through entire regimen; treated every 3 weeks
Drug: Paclitaxel
cycle #1 and continuous through entire regimen; treated every 3 weeks
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030 | |
| Principal Investigator: | Carolyn Runowicz, MD | University of Connecticut Health Center |
More Information
| Responsible Party: | Univ. of CT Health Center ( Carolyn Runowicz, MD ) |
| Study ID Numbers: | AVF 3696s, IRB 06-337-1 |
| Study First Received: | December 5, 2006 |
| Last Updated: | January 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00408070 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
ovarian cancer fallopian tube cancer peritoneal cancer |
|
Fallopian Tube Cancer Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Bevacizumab Genital Diseases, Female Peritoneal Diseases Ovarian Cancer Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases Carboplatin |
Antimitotic Agents Abdominal Neoplasms Angiogenesis Inhibitors Fallopian Tube Neoplasms Carcinoma Fallopian Tube Diseases Digestive System Diseases Paclitaxel Tubulin Modulators Gastrointestinal Neoplasms Peritoneal Neoplasms Endocrinopathy Antineoplastic Agents, Phytogenic |
|
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Bevacizumab Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Growth Inhibitors Angiogenesis Modulating Agents Endocrine Gland Neoplasms Ovarian Neoplasms |
Digestive System Neoplasms Growth Substances Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Antimitotic Agents Carboplatin Abdominal Neoplasms Angiogenesis Inhibitors Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases |
