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

NCT ID: NCT00034463

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Metastases Cancer

Keywords

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metastatic cancer chemotherapy

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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ALIMTA

Intervention Type DRUG

folic acid

Intervention Type DRUG

multi-vitamins

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H3E-MC-JMAS

Identifier Type: -

Identifier Source: secondary_id

1310

Identifier Type: -

Identifier Source: org_study_id