Abraxane Plus Carboplatin for Recurrent Platinum-Sensitive Ovarian Cancer | RxWiki

Abraxane Plus Carboplatin for Recurrent Platinum-Sensitive Ovarian Cancer

Overview[ - collapse ][ - ]

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	Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer
Intervention	Drug: Abraxane
Phase	Phase 2
Sponsor	Southeastern Gynecologic Oncology
Responsible Party	Southeastern Gynecologic Oncology
ClinicalTrials.gov Identifier	NCT00466986
First Received	April 26, 2007
Last Updated	October 7, 2011
Last verified	October 2011

Tracking Information[ + expand ][ + ]

First Received Date	April 26, 2007
Last Updated Date	October 7, 2011
Start Date	November 2005
Estimated Primary Completion Date	October 2011
Current Primary Outcome Measures	Response Rate [Time Frame: 5 years] [Designated as safety issue: No]
Current Secondary Outcome Measures	Time to Response [Time Frame: 5 years] [Designated as safety issue: No] Duration of Response [Time Frame: 5 years] [Designated as safety issue: No] Overall Survival [Time Frame: 5 years] [Designated as safety issue: No] Progression Free Survival [Time Frame: 5 years] [Designated as safety issue: No] Safety [Time Frame: 5 years] [Designated as safety issue: Yes] Tolerability [Time Frame: 5 years] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Abraxane Plus Carboplatin for Recurrent Platinum-Sensitive Ovarian Cancer
Official Title	A Phase II, Non-Randomized Study of Abraxane Plus Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer
Brief Summary	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.
Detailed Description	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. 1. No need for routine premedications 2. Increased drug entry into cells facilitating greater potential for anti-tumor activity. Schedule: Carboplatin day1 every 28days. Abraxane day1,8,15 every 28days.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer
Intervention	Drug: Abraxane Carboplatin day1 every 28days. Abraxane day1,8,15 every 28days
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	40
Estimated Completion Date	October 2011
Estimated Primary Completion Date	October 2011
Eligibility Criteria	Inclusion Criteria: 1. Histologically or cytologically confirmed recurrent epithelial ovarian or primary peritoneal carcinoma. Patient will have been staged at diagnosis according to FIGO Classification. 2. Measurable Disease by RECIST Criteria (defined by the presence of at least 1 measurable lesion (see Section 7.7.1 for definition of measurable lesions) or elevated CA-125 in the absence of measurable disease. A pre-treatment sample of CA-125 will be collected within 2 weeks before treatment is started. A pre-treatment sample of CA-125 should be at least twice the upper limit of normal. 3. Patients must have disease recurrence 6 months or more after completion of front-line platinum and paclitaxel-containing regimen. Duration of response from prior therapy and prior consolidation therapy will be documented in case report forms for descriptive analysis. 4. Patients must have received at least 3 cycles of a front-line taxane and platinum-containing regimen prior to entry on this study. 5. Patients must have a documented complete clinical response on front-line therapy. 6. Patients must be disease-free from prior malignancies for more than 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. 7. Life expectancy of > 6 months. 8. ECOG (Zubrod) performance status 0-2. 9. Age >18 years. 10. Patient has the following blood counts at Baseline: - ANC > 1.5 x 10-9 c/L; - platelets > 100 x 10-9 c/L; - Hgb > 9 g/dL. 11. Patient has the following blood chemistry levels at Baseline: - AST (SGOT), ALT (SGPT) < 1.5x upper limit of normal range (ULN); - total bilirubin NORMAL; - alkaline phosphatase < 2.5x ULN - creatinine < 1.5 mg/dL. 12. Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities. Exclusion Criteria: 1. Patients who have received more than one prior chemotherapy regimen. 2. Evidence of active brain metastases, including leptomeningeal involvement. Prior evidence of brain metastasis permitted only if treated and stable off therapy for at least 1 month. 3. Patient has pre-existing peripheral neuropathy of grade >/= 2 (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 3.0 [CTCAE]. 4. Patients receiving concurrent or intervening other chemotherapy, hormonal (for treatment of ovarian carcinoma), immunotherapy, or radiotherapy. 5. Patient has a clinically significant concurrent illness. 6. Patient is, in the Investigator's opinion, unlikely to be able to complete the study through the End of Study (EOS) visit. 7. Patient has a history of allergy or hypersensitivity to the study drug. 8. Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug. 9. Patient is enrolled in any other clinical protocol or investigational trial. 10. Patients of childbearing potential, not practicing adequate contraception.
Gender	Female
Ages	N/A
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00466986
Other Study ID Numbers	WIRB#20051730
Has Data Monitoring Committee	No
Information Provided By	Southeastern Gynecologic Oncology
Study Sponsor	Southeastern Gynecologic Oncology
Collaborators	Celgene Corporation
Investigators	Principal Investigator: Benidict B Benigno, MD Southeastern Gynecologic Oncology
Verification Date	October 2011

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