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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Letrozole — DRUG
  Given PO
• Paclitaxel — DRUG
  Given IV
• Pegylated Liposomal Doxorubicin Hydrochloride — DRUG
  Given IV
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies
• Tamoxifen Citrate — DRUG
  Given PO
• Topotecan — DRUG
  Given IV
• Trametinib Dimethyl Sulfoxide — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Apr 11, 2014

Status verified

Oct 2025

Primary completion

Apr 4, 2019

Completion

Oct 27, 2025

Study Design

Enrollment

260 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (letrozole, tamoxifen, paclitaxel, PLD, topotecan)
  Patients receive clinician's choice of either letrozole PO QD on days 1-28, tamoxifen citrate PO BID on days 1-28, paclitaxel IV over 1 hour on days 1, 8, and 15, pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or topotecan IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients developing progressive disease may cross over to Arm B.
• Experimental: Arm B (trametinib)
  Patients receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B ]

Locations (488)

Find similar trials in Huntsville, AL

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