Fallopian Tube Cancer
This is an open-label, multicenter study with a nonrandomized Phase 1 portion and an open-label, randomized, Phase 2 portion evaluating MLN8237 in combination with weekly paclitaxel in adult female patients with advanced breast cancer (Phase 1 portion only) and recurrent ovarian cancer (both Phase 1 and Phase 2 portions).
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Female patients 18 years or older
- Previously treated, metastatic or locally recurrent malignancy with 1 of the following diagnoses, which has been confirmed histologically or cytologically: adenocarcinoma of the breast (Phase 1 only), recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (Phase 1 and 2).
- Patients with breast cancer must have received treatment with at least 1 but no more than 4 prior chemotherapy regimens not including regimens received in the neoadjuvant and/or adjuvant setting
- Patients with breast cancer must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- No antineoplastic therapy or radiotherapy within 3 weeks before enrollment (2 weeks for regimens with recovery expected within 7 to 14 days) and recovered from toxicities of prior therapy (except alopecia); the patient must have recovered from all treatment-related toxicities and must have evidence of PD or persistent disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow, liver and renal function, and serum albumin > lower limit of normal (LLN)
- Postmenopausal at least 1 year, OR Surgically sterile, OR If childbearing potential, agree to 2 effective methods of nonhormonal contraception, or agree to completely abstain from heterosexual intercourse
- Able to provide written informed consent
- Willing to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
- Suitable venous access
Specific Inclusion Criteria for Patients with Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer:
- Prior treatments must have included a platinum and a taxane (not a weekly taxane regimen). Disease must have recurred ≤ 12 months after discontinuation of platinum therapy.
- Measurable disease in target lesions or assessable disease (defined by CA-125 per protocol)
- Disease that has progressed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or modified Gynecologic Cancer Intergroup (GCIG) CA-125 criteria
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.