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An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer

12:07 EDT 20th April 2014 | BioPortfolio

Summary

This study tests the safety and effectiveness of a YONDELIS® (trabectedin) and DOXIL/CAELYX (herein referred to as DOXIL) combination to DOXIL alone.

Description

This is a multicenter, open-label, randomized, Phase 3 study comparing the combination of Doxil, 30mg/m2, administered as a 90-minute infusion followed by trabectedin, 1.1 mg/m2 3-hour infusion, every 3 weeks with DOXIL, 50 mg/m2 as a 90-minute infusion every 4 weeks, in previously treated patients with advanced ovarian cancer for whom first-line platinum-based chemotherapy regimen has failed. The purpose of this research study is to determine if the combination of trabectedin and DOXIL is better at improving progression free survival over DOXIL alone in patients with relapsed advanced ovarian cancer. Additional comparisons between the two treatment groups include: overall survival, measurement of disease progression, response rate, (how much your tumor shrinks in response to the drug) safety, pharmacokinetics (measuring the amount of drug in your body), quality of life, and optional measurement of circulating tumor cells if present. Patients may receive either a combination of trabectedin and DOXIL (Group A) or DOXIL alone (Group B). If you are in Group A you will receive dexamethasone followed by Trabectedin 1.1 mg/m┬▓ as a 3 hour infusion + DOXIL 30 mg/m┬▓ every 3 weeks as long as you are responding to treatment. If you are in Group B you will receive DOXIL 50 mg/m2 every 4 weeks as long as you are responding to treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Ovarian Cancer

Intervention

DOXIL, trabectedin + DOXIL

Status

Active, not recruiting

Source

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.

Cessation of ovarian function after MENARCHE but before the age of 40, without or with OVARIAN FOLLICLE depletion. It is characterized by the presence of OLIGOMENORRHEA or AMENORRHEA, elevated GONADOTROPINS, and low ESTRADIOL levels. It is a state of female HYPERGONADOTROPIC HYPOGONADISM. Etiologies include genetic defects, autoimmune processes, chemotherapy, radiation, and infections.

Cessation of ovarian function after MENARCHE but before the age of 40, without or with OVARIAN FOLLICLE depletion. It is characterized by the presence of OLIGOMENORRHEA or AMENORRHEA, elevated GONADOTROPINS, and low ESTRADIOL levels. It is a state of female HYPERGONADOTROPIC HYPOGONADISM. Etiologies include genetic defects, autoimmune processes, chemotherapy, radiation, and infections.

A complication of OVULATION INDUCTION in infertility treatment. It is graded by the severity of symptoms which include OVARY enlargement, multiple OVARIAN FOLLICLES; OVARIAN CYSTS; ASCITES; and generalized EDEMA. The full-blown syndrome may lead to RENAL FAILURE, respiratory distress, and even DEATH. Increased capillary permeability is caused by the vasoactive substances, such as VASCULAR ENDOTHELIAL GROWTH FACTORS, secreted by the overly-stimulated OVARIES.

A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)

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