Abraxane Plus Carboplatin for Recurrent Platinum-Sensitive Ovarian Cancer
NCT ID: NCT00466986
Last Updated: 2011-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2005-11-30
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abraxane
Carboplatin day1 every 28days. Abraxane day1,8,15 every 28days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Celgene Corporation
INDUSTRY
Southeastern Gynecologic Oncology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Benidict B Benigno, MD
Role: PRINCIPAL_INVESTIGATOR
Southeastern Gynecologic Oncology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Southeastern Gynecologic Oncology
Atlanta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WIRB#20051730
Identifier Type: -
Identifier Source: org_study_id