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

Lilly

Status and phase

Completed

Phase 2

Phase 1

Conditions

Primary Peritoneal Cancer

Ovarian Cancer

Treatments

Drug: Carboplatin - Phase 2

Drug: Pemetrexed - Phase 1

Drug: Carboplatin - Phase 1

Drug: Pemetrexed - Phase 2

Study type

Interventional

Funder types

Industry

Identifiers

NCT00489359

H3E-MC-JMHH (Other Identifier)

9516

Details and patient eligibility

About

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.

Enrollment

86 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of ovarian or primary peritoneal cancer confirmed by pathology
Patients must have recurrent ovarian cancer which is sensitive to platinum therapy
Prior radiation therapy is allowed

Measurable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines, or non-measurable but cancer antigen 125 (CA-125) greater than or equal to 2X upper limit.

Exclusion criteria

More than 2 lines of therapy for ovarian or primary peritoneal cancer.
Pregnant or breast feeding.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

86 participants in 2 patient groups

Pemetrexed/Carboplatin Phase 1

Experimental group

Description:

Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.

Treatment: