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| Sponsor: | Southeastern Gynecologic Oncology |
|---|---|
| Collaborator: |
Celgene Corporation |
| Information provided by (Responsible Party): | Southeastern Gynecologic Oncology |
| ClinicalTrials.gov Identifier: | NCT00466986 |
Purpose
The purpose of this study is to determine if the combination of Abraxane and Carboplatin together will improve the chances of controlling recurrent ovarian/fallopian tube/peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer |
Drug: Abraxane |
Phase II |
| 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, Non-Randomized Study of Abraxane Plus Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer |
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2005 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Current best practice recommends Carboplatin combined with Taxol in the treatment of Ovarian cancer.
Taxol is paclitaxel in the solvent Cremophor-El and the solvent has been associated with significant side effects e.g. anaphylaxis and hypersensitivity. this requires the routine use of premedication with antihistamines and steroids.
Abraxane by contrast is Cremophor-El free and is protein bound. This has 2 advantages over Taxol.
Schedule: Carboplatin day1 every 28days. Abraxane day1,8,15 every 28days.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient has the following blood counts at Baseline:
Patient has the following blood chemistry levels at Baseline:
Exclusion Criteria:
Contacts and Locations| United States, Georgia | |
| Southeastern Gynecologic Oncology | |
| Atlanta, Georgia, United States, 30342 | |
| Principal Investigator: | Benidict B Benigno, MD | Southeastern Gynecologic Oncology |
More Information
| Responsible Party: | Southeastern Gynecologic Oncology |
| ClinicalTrials.gov Identifier: | NCT00466986 History of Changes |
| Other Study ID Numbers: | WIRB#20051730 |
| Study First Received: | April 26, 2007 |
| Last Updated: | October 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
recurrent ovarian cancer platinum sensitive |
|
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 Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |