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Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer

NCT02101788 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-11-13

Study results available
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Summary

This phase II/III trial studies how well trametinib works and compares it to standard treatment with either letrozole, tamoxifen, paclitaxel, pegylated liposomal doxorubicin, or topotecan in treating patients with low-grade ovarian cancer or peritoneal cavity cancer that has come back (recurrent), become worse (progressive), or spread to other parts of the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib is more effective than standard therapy in treating patients with ovarian or peritoneal cavity cancer.

Conditions

  • Borderline Ovarian Serous Tumor
  • Micropapillary Serous Carcinoma
  • Ovarian Serous Adenocarcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Recurrent Ovarian Low Grade Serous Adenocarcinoma
  • Recurrent Primary Peritoneal Serous Adenocarcinoma

Interventions

DRUG

Letrozole

Given PO

DRUG

Paclitaxel

Given IV

DRUG

Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Tamoxifen Citrate

Given PO

DRUG

Topotecan

Given IV

DRUG

Trametinib Dimethyl Sulfoxide

Given PO

Sponsors & Collaborators

  • NRG Oncology

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • David M Gershenson · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-11
Primary Completion
2019-04-04
Completion
2025-10-27

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101788 on ClinicalTrials.gov