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Melanotan-I

Afamelanotide, MT-I, [Nle4-D-Phe7]-α-MSH, Scenesse, CUV-1647

Quick Stats
Studies 225
Trials 100
Completed PHASE3 INTERVENTIONAL NCT00063999

Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This randomized phase III trial compares how well two different combination chemotherapy regimens (doxorubicin hydrochloride, cisplatin, and paclitaxel versus carboplatin and paclitaxel) work in treating patients with endometrial cancer that is stage III-IV or has come back (recurrent). Drugs used in chemotherapy such as doxorubicin hydrochloride, cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known which combination chemotherapy regimen is more effective in treating endometrial cancer.

Detailed Description

PRIMARY OBJECTIVES: I. To determine if the combination of carboplatin and paclitaxel (TC) chemotherapy is therapeutically equivalent to the combination of doxorubicin (doxorubicin hydrochloride), cisplatin and paclitaxel (TAP) chemotherapy with regards to survival. II. To determine if estrogen/progesterone receptor status provides prognostic information in patients treated with chemotherapy. III. To assess whether combination TC chemotherapy is superior to combination TAP chemotherapy with regards to toxicity profile, specifically neurotoxicity and infection. IV. To measure differences in patient-reported neurotoxicity and quality of life (QOL) among the regimens. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients with left ventricular ejection fraction \< 50% at randomization who are initially randomized to Arm I are immediately crossed over to Arm II. ARM I: Patients receive doxorubicin hydrochloride intravenously (IV) over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim subcutaneously (SC) on days 3-12 or pegfilgrastim SC on day 3. ARM II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. In both arms, treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Interventions

Name: Carboplatin
Type: DRUG
Description: Given IV
Name: Cisplatin
Type: DRUG
Description: Given IV
Name: Doxorubicin Hydrochloride
Type: DRUG
Description: Given IV
Name: Filgrastim
Type: BIOLOGICAL
Description: Given SC
Name: Laboratory Biomarker Analysis
Type: OTHER
Description: Correlative studies
Name: Paclitaxel
Type: DRUG
Description: Given IV
Name: Pegfilgrastim
Type: BIOLOGICAL
Description: Given SC
Name: Quality-of-Life Assessment
Type: OTHER
Description: Ancillary studies

Primary Outcomes

Measure: Number of Participants Alive at Time of Last Follow-up.
TimeFrame: Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years.
Description: The time alive in months from study entry to last contact or death.

Trial Information

NCT ID

NCT00063999

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

GOG Foundation

Last Updated

December 15, 2025