Mixed Tumor, Mullerian Clinical Trial
Official title:
A Phase II Multicenter Trial of Paclitaxel and Carboplatin in Women With Advanced (IIIb, IIIc, IVa and IVb) or Recurrent (All Stages) Malignant Mixed Mullerian Tumors (MMMT) of the Uterus
| Verified date | December 2011 |
| Source | M.D. Anderson Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The goal of this clinical research study is to find out if the combination of paclitaxel and carboplatin chemotherapy can shrink or slow the growth of mixed mullerian tumors (MMMT) of the uterus.
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | November 2010 |
| Est. primary completion date | November 2010 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Lyndon Baines Johnson Hospital | Houston | Texas |
| United States | UT MD Anderson Cancer Center | Houston | Texas |
| United States | Loma Linda Cancer Institute | Loma Linda | California |
| United States | MD Anderson Cancer Center | Orlando | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| M.D. Anderson Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Overall Response | Overall response rate including complete (CR) and partial responses (PR) with measurable disease using Response Evaluation Criteria In Solid Tumors (RECIST) assessment. CR: Disappearance of all target and non-target lesions; no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. PR: At least 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD; no unequivocal progression of non-target lesions and no new lesions. Documentation by 2 disease assessments at least 4 weeks apart is required. | 24 Months | No |