Phase 2
N=23
Paclitaxel and Carboplatin in Women With Malignant Mixed Mullerian Tumors (MMMT) of the Uterus
Mixed Tumor, Mullerian
Bottom Line
View on ClinicalTrials.gov: NCT00502203 ↗Enrolled (actual)
23
Serious AEs
39.1%
Results posted
Jan 2012
Primary outcome: Primary: Number of Participants With Overall Response — 8 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carboplatin (Drug); Paclitaxel (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Overall Response |
8 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients with histologically confirmed advanced (IIIb, IIIc, IVa and IVb) or recurrent (all stages) MMMT.
- Prior chemotherapy is permitted with the exception of patients previously treated with platinum and/or taxol chemotherapy for this disease.
- Women of any racial and ethnic group.
- Eastern Cooperative Oncology Group (ECOG) performance status /= 12 weeks.
- Patients must have recovered from the side effects of prior therapy (chemotherapy, surgery, or radiation) before entering the study.
- Adequate liver, renal, and bone marrow function, defined as: a total bilirubin value /= 1,500/ul; platelet count >/= 100,000/ul. All qualifying laboratory parameters must be determined within 1 week prior to first treatment.
- Participants must agree to practice approved methods of birth control (if applicable).
- Patients must sign an institutionally approved informed consent.
Exclusion Criteria
- Patients with a Zubrod performance status of 3 or greater.
- Concurrent cancer chemotherapy, radiotherapy or surgery.
- 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.
- Presence of known untreated brain metastases.
- Overt psychosis or mental disability or otherwise incompetent to give informed consent.
- Patients with an active systemic infection.
- Patients with a serious intercurrent medical illness.
- Patients with a history of neuropsychiatric or seizure disorders.
Data sourced from ClinicalTrials.gov (NCT00502203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.