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About
The primary purpose of this study is to determine the maximum tolerated dose and dose-limiting toxicities (DLTs) of weekly and every 3-weeks ABI-007 in combination with carboplatin (area under the curve [AUC]=6) in patients with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Enrollment
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Inclusion criteria
Patients with a histological diagnosis of primary peritoneal carcinoma, fallopian tube or epithelial ovarian carcinoma (Stage III or IV) with either (optimal less than or equal to 1 cm) residual disease or suboptimal residual disease following initial appropriate surgery.
Patients with the following histologically confirmed types of ovarian cancer are eligible: serous cystadenocarcinoma, mucinous cystadenocarcinoma, clear cell adenocarcinoma, adenocarcinoma (unspecified), malignant Brenner's tumor, endometrioid adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma and transitional cell carcinoma. Patients with extraovarian papillary serous cystadenocarcinoma are eligible.
Patients who do not have measurable disease may be included and will be assessed for toxicity and progression-free survival only. Measurable disease is NOT required but when present will be followed to assess response. For patients to be evaluated for response of measurable disease, tumor must be greater than or equal to 2.0 cm with conventional computed tomography (CT) imaging or greater than or equal to 1.0 cm with spiral CT imaging.
No prior chemotherapy for ovarian cancer is permitted.
Patients must be entered no more than 12 weeks postoperatively.
ECOG performance status 0-2.
Age greater than or equal to 18 years.
Patient has the following blood counts at Baseline:
Patient has the following blood chemistry levels at Baseline:
Peripheral neuropathy Grade 0 or 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
It is assumed that almost all patients already had bilateral oophorectomy. However, if a female of childbearing potential, has a negative pregnancy test (within 72 hours of the first dose of study drug), the patient must agree to use an effective method to avoid pregnancy for the duration of the study.
Patients must have signed an approved informed consent and authorization permitting the release of personal health information.
Exclusion criteria
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Data sourced from clinicaltrials.gov
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