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Phase 3 N=260 Randomized Treatment

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

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

Enrolled (actual)
260
Serious AEs
33.0%
Results posted
Sep 2020
Primary outcome: Primary: Progression-free Survival (PFS) — 7.2; 13.0 months

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Letrozole (Drug); Paclitaxel (Drug); Pegylated Liposomal Doxorubicin Hydrochloride (Drug); Quality-of-Life Assessment (Other); Questionnaire Administration (Other); Tamoxifen Citrate (Drug); Topotecan (Drug); Trametinib Dimethyl Sulfoxide (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
National Cancer Institute (NCI)
Primary completion
Apr 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-free Survival (PFS)
7.2; 13.0
SECONDARY
Incidence of Adverse Events (AEs)
22; 7; 12; 16; 4; 13
SECONDARY
Overall Survival
29.2; 37.0
SECONDARY
Objective Tumor Response Rate (Complete Response and Partial Response)
8; 34
SECONDARY
Patients Reported Acute Quality of Life
74.5; 74.5; 74.2; 70.6; 70.2; 73.0
SECONDARY
Patient Reported Acute Peripheral Neuropathy Symptoms
13.2; 12.8; 12.5; 12.6; 12.4; 12.1
SECONDARY
Progression Free Survival
13.2; 11.4; 7.3; 6.3 0.0929
SECONDARY
pERK Expression

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.

Eligibility Criteria

Inclusion Criteria

  • Patients age greater than 18 with the following tumors are included in the study:
  • Patients initially diagnosed with low-grade serous ovarian or peritoneal carcinoma that recur as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, Federation of Obstetricians and Gynecologists [FIGO], World Health Organization [WHO] or Silverberg)
  • Patients initially diagnosed with serous borderline ovarian or peritoneal carcinoma that recur as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO or Silverberg)
  • At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g. MAJOR: laparotomy, laparoscopy, thoracotomy, VATS [video assisted thorascopic surgery]); there is no restriction on MINOR procedures: (e.g. central venous catheter placement, ureteral stent placement or exchange, tumor core or fine-needle aspirate [FNA] biopsy)
  • Patients must have documented low-grade serous carcinoma; confirmation must occur by prospective pathology review prior to study entry; the prospective pathology review can be done on tissue from the recurrent carcinoma or from original diagnostic specimen
  • All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one target lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI; all imaging studies must be performed within 28 days prior to registration
  • Prior therapy
  • Patients must have recurred or progressed following at least one platinum-based chemotherapy regimen
  • Patients may have received an unlimited number of prior therapy regimens
  • Patients may not have received all of the five choices in the "standard therapy" arm
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
  • Any other prior therapy directed at the malignant tumor, including chemotherapy and radiation therapy, must be discontinued at least 4 weeks prior to registration; any investigational agent must be discontinued at least 28 days prior to registration
  • Trametinib, can cause fetal harm when administered to a pregnant woman; women of child-bearing potential (i.e. patients whose reproductive organs remain in place and who have not passed menopause) and men must agree to use a highly effective method of contraception (e.g. hormonal, intrauterine device or; abstinence*) prior to study entry, during the study participation, and for six months after the last dose of the drug; women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to randomization, cannot be breast-feeding, and must agree to use a highly effective form of contraception throughout the treatment period and for 6 months after the last dose of study treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Abstinence is only acceptable when this is in line with the preferred and usual lifestyle of the patient
  • Patients must have the ability to understand and sign an approved informed consent and authorization permitting release of personal health information
  • Patients must have a GOG performance status of 0 or 1
  • Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome, bowel obstruction, or major resection of the stomach o
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02101788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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