Paclitaxel and Carboplatin in Women With Malignant Mixed Mullerian Tumors (MMMT) of the Uterus

NCT00502203 | Completed Phase 2 Results

• 1 other identifier: ID01-229
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Mixed Tumor, Mullerian

Keywords

Uterine Neoplasms; Endometrial Cancer; Paclitaxel; Taxol; Carboplatin; Paraplatin; Malignant Mixed Mullerian Tumors; MMMT; Immunohistochemical markers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Paclitaxel + Carboplatin

EXPERIMENTAL

Paclitaxel 175 mg/m\^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.

Drug: Carboplatin; Drug: Paclitaxel

Interventions

Carboplatin DRUG

AUC 5 By Vein Over 1 Hour Every 21 Days for 6 Courses

Also known as: Paraplatin

Paclitaxel + Carboplatin

Paclitaxel DRUG

175 mg/m\^2 By Vein Over 3 Hours Every 21 Days for 6 Courses

Also known as: Taxol

Paclitaxel + Carboplatin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \</= 2.
• Expected survival of \>/= 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 \</= 1.5 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.
• Participants must agree to practice approved methods of birth control (if applicable).
• Patients must sign an institutionally approved informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (4)

Loma Linda Cancer Institute

Loma Linda, California, 92354, United States

Location

MD Anderson Cancer Center

Orlando, Florida, 32806, United States

Location

Lyndon Baines Johnson Hospital

Houston, Texas, 77030, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Mixed Tumor, Mullerian; Uterine Neoplasms; Endometrial Neoplasms

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Lois M. Ramondetta, MD / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Lois M. Ramondetta, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 17, 2007
• Study Start: August 1, 2001
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 9, 2016
• Results First Posted: January 9, 2012

Record last verified: 2011-12

Locations

US (4)