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Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer

NCT00489359 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2011-06-16

Study results available
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Summary

The purpose of this study is to determine efficacy of the combination therapy of pemetrexed and carboplatin as treatment for patients with platinum-sensitive ovarian cancer. This study also includes patients with primary peritoneal cancer.

Conditions

Interventions

DRUG

Pemetrexed - Phase 2

Dose determined from Phase 1: 500 mg/m\^2, administered IV, every 21 days x 6 cycles

DRUG

Carboplatin - Phase 2

Dose determined from Phase 1: AUC 6 mg/mL\*min, administered IV, every 21 days x 6 cycles

DRUG

Pemetrexed - Phase 1

500, 600, 700, 800, or 900 milligrams per square meter (mg/m\^2), administered intravenously (IV), every 21 days x 6 cycles, dose escalate to Maximum Tolerated Dose (MTD)

DRUG

Carboplatin - Phase 1

area under the concentration time curve (AUC) 5 or 6 mg/mL\*min, administered intravenously (IV), every 21 days x 6 cycles, dose escalation to Maximum Tolerated Dose (MTD)

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Argentina
  • Canada
  • Germany
  • Poland
  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00489359 on ClinicalTrials.gov