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

A Phase 1 Trial of ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00034463
Enrollment
Unknown
Registered
2002-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2006-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastases, Cancer

Keywords

metastatic cancer, chemotherapy

Brief summary

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.

Interventions

DRUGALIMTA
DRUGfolic acid

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026