Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT00502203
Eligibility Criteria:
Inclusion Criteria:
1. Patients with histologically confirmed advanced (IIIb, IIIc, IVa and IVb) or recurrent (all stages) MMMT.
2. Prior chemotherapy is permitted with the exception of patients previously treated with platinum and/or taxol chemotherapy for this disease.
3. Women of any racial and ethnic group.
4. Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
5. Expected survival of \>/= 12 weeks.
6. Patients must have recovered from the side effects of prior therapy (chemotherapy, surgery, or radiation) before entering the study.
7. Adequate liver, renal, and bone marrow function, defined as: a total bilirubin value \</= 1.5 mg/dL; serum glutamic pyruvic transaminase (SGPT) \</= 2 times upper limit of normal or \</= 5 times upper limit of normal when liver metastases are present; serum creatinine \</= 1.5 mg/dL; Absolute neutrophil count (ANC) \>/= 1,500/ul; platelet count \>/= 100,000/ul. All qualifying laboratory parameters must be determined within 1 week prior to first treatment.
8. Participants must agree to practice approved methods of birth control (if applicable).
9. Patients must sign an institutionally approved informed consent.
Exclusion Criteria:
1. Patients with a Zubrod performance status of 3 or greater.
2. Concurrent cancer chemotherapy, radiotherapy or surgery.
3. History of other malignancy (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 5 years.
4. Presence of known untreated brain metastases.
5. Overt psychosis or mental disability or otherwise incompetent to give informed consent.
6. Patients with an active systemic infection.
7. Patients with a serious intercurrent medical illness.
8. Patients with a history of neuropsychiatric or seizure disorders.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00502203
Study Brief:
Protocol Section:
NCT00502203