Alimta, Carboplatin and Radiation Therapy for Non Small Cell Lung Cancer

NCT00330044 | Completed Phase 1 DMC

• 3 other identifiers: 05C.2762005-19JT 1070
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the safety of Alimta when used with chemoradiation in inoperable non small cell lung cancer

Conditions

Inoperable Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Response and Progression Free Survival

  Up to five years after study completion

Study Arms (1)

Drug

EXPERIMENTAL

Carboplatin and Pemetrexed

Drug: Premetrexed (Alimta); Drug: Carboplatin

Interventions

Premetrexed (Alimta) DRUG

Drug

Carboplatin DRUG

Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unresectable Stage II, IIIB or IV non small cell lung cancer. Evaluable disease on planning CT scan Zubrod 0-1 Weight loss equal to or less than 10% 3 months prior to diagnosis FEV1 greater than 1000cc Adequate hematologic, renal and hepatic functions

You may not qualify if:

• Small cell cancer Stage I non small cell cancer Prior chemotherapy or thoracic or lower neck radiatio therapy

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Kimmel Cancer Center at Thomas Jefferson University
• Thomas Jefferson University Hospital

MeSH Terms

Interventions

Pemetrexed; Carboplatin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Maria Werner-Wasik, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2006
• First Posted: May 25, 2006
• Study Start: April 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 2, 2025

Record last verified: 2025-05

Locations

US (1)