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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abraxane | Drug | Carboplatin day1 every 28days. Abraxane day1,8,15 every 28days |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Response | 5 years | |
| Duration of Response | 5 years | |
| Overall Survival |
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Inclusion Criteria:
Histologically or cytologically confirmed recurrent epithelial ovarian or primary peritoneal carcinoma. Patient will have been staged at diagnosis according to FIGO Classification.
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.
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.
Patients must have received at least 3 cycles of a front-line taxane and platinum-containing regimen prior to entry on this study.
Patients must have a documented complete clinical response on front-line therapy.
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.
Life expectancy of > 6 months.
ECOG (Zubrod) performance status 0-2.
Age >18 years.
Patient has the following blood counts at Baseline:
Patient has the following blood chemistry levels at Baseline:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Benidict B Benigno, MD | Southeastern Gynecologic Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeastern Gynecologic Oncology | Atlanta | Georgia | 30342 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D012008 | Recurrence |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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| 5 years |
| Progression Free Survival | 5 years |
| Safety | 5 years |
| Tolerability | 5 years |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |