Trial Outcomes & Findings for Paclitaxel and Carboplatin in Women With Malignant Mixed Mullerian Tumors (MMMT) of the Uterus (NCT NCT00502203)

NCT ID: NCT00502203

Last Updated: 2016-05-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: 24 Months
• Results posted on: 2016-05-09

Participant Flow

Recruitment period: August 29, 2001 to May 08, 2009. All recruitment was done at medical clinics.

Participant milestones

Measure	Paclitaxel + Carboplatin Paclitaxel 175 mg/m\^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
Overall Study STARTED	23
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	1

Reasons for withdrawal

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

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Paclitaxel + Carboplatin n=23 Participants Paclitaxel 175 mg/m\^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Months

Population: Thirteen participants had measurable disease therefore evaluable for a complete or partial 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.

Outcome measures

Measure	Paclitaxel + Carboplatin n=13 Participants Paclitaxel 175 mg/m\^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
Number of Participants With Overall Response	8 participants

Adverse Events

Paclitaxel + Carboplatin

Serious events: 9 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paclitaxel + Carboplatin n=23 participants at risk Paclitaxel 175 mg/m\^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
Blood and lymphatic system disorders Neutropenia	39.1% 9/23 • 7 years and 11 months

Other adverse events

Measure	Paclitaxel + Carboplatin n=23 participants at risk Paclitaxel 175 mg/m\^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
General disorders Allergic Reaction	8.7% 2/23 • 7 years and 11 months
Skin and subcutaneous tissue disorders Alopecia	100.0% 23/23 • 7 years and 11 months
Blood and lymphatic system disorders Anemia	39.1% 9/23 • 7 years and 11 months
Gastrointestinal disorders Anorexia	34.8% 8/23 • 7 years and 11 months
Gastrointestinal disorders Constipation	21.7% 5/23 • 7 years and 11 months
General disorders Fatigue	91.3% 21/23 • 7 years and 11 months
General disorders Headache	8.7% 2/23 • 7 years and 11 months
Metabolism and nutrition disorders Hypomagnesemia	4.3% 1/23 • 7 years and 11 months
Infections and infestations Infection	4.3% 1/23 • 7 years and 11 months
Nervous system disorders Neuropathy (sensory)	60.9% 14/23 • 7 years and 11 months
Nervous system disorders Neuropathy (hearing)	13.0% 3/23 • 7 years and 11 months
Blood and lymphatic system disorders Neutropenia	47.8% 11/23 • 7 years and 11 months
Blood and lymphatic system disorders Neutropenic Fever	13.0% 3/23 • 7 years and 11 months
Gastrointestinal disorders Mucositis	4.3% 1/23 • 7 years and 11 months
Musculoskeletal and connective tissue disorders Myalgia	65.2% 15/23 • 7 years and 11 months
Gastrointestinal disorders Nausea	47.8% 11/23 • 7 years and 11 months
Blood and lymphatic system disorders Thrombocytopenia	4.3% 1/23 • 7 years and 11 months
Gastrointestinal disorders Vomiting	21.7% 5/23 • 7 years and 11 months

Additional Information

Lois M. Ramondetta, MD / Professor

UT MD Anderson Cancer Center

Email: CR_Study_Registration@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place