ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer

Lilly

Status and phase: Completed; Phase 1

Conditions: Metastases; Cancer

Treatments: Drug: multi-vitamins; Drug: folic acid; Drug: ALIMTA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00034463

H3E-MC-JMAS

1310

Details and patient eligibility

About

This is a non-randomized, phase 1, study with the primary objective of determining the toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10 minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in lightly or heavily pre-treated patients with locally advanced or metastatic cancer.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic or cytologic diagnosis of metastatic or locally advanced cancer
• Prior chemotherapy is allowed
• Adequate bone marrow, liver and kidney function

Exclusion criteria

• Prior treatment with ALIMTA
• Brain metastasis
• Pregnancy or breast feeding