Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer

NCT00383331 | Terminated Phase 2 Results

• 2 other identifiers: 9431H3E-US-S061
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity respectively in patients with locally advanced or metastatic NSCLC. Therefore, it is reasonable to investigate the most optimal schedule for this combination, and which combination is associated with the most anti-tumor activity in the phase II arena.

Conditions

Non-Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Best Overall Tumor Response

  Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

  baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up

Secondary Outcomes (5)

• Progression Free Survival

  baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up

• Time to Progressive Disease

  baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up

• Duration of Response

  baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up

• Time to Treatment Failure

  baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up

• Overall Survival

  baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up

Study Arms (2)

A

EXPERIMENTAL

Drug: Pemetrexed; Drug: Gemcitabine

B

EXPERIMENTAL

Drug: Pemetrexed; Drug: Gemcitabine

Interventions

Pemetrexed DRUG

A: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles

Also known as: LY231514, Alimta

A; B

Gemcitabine DRUG

A: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles

Also known as: LY188011, Gemzar

A; B

Eligibility Criteria

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

You may qualify if:

• histologic or cytologic diagnosis of NSCLC Stage IIIB or IV
• no prior systemic chemotherapy for advanced Non-Small Cell Lung Cancer
• Prior radiotherapy must be completed at least 4 weeks before study enrollment.

You may not qualify if:

• estimated life expectancy of 12 weeks
• a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
• documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 2 weeks before enrollment
• significant weight loss (that is, \> 10%) over the previous 6 weeks before study entry.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Rochester, Minnesota, 55905, United States

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Trial was stopped early due to low enrollment. Some secondary outcomes were not analyzed due to the low numbers.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 3, 2006
• Study Start: February 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: June 3, 2009
• Results First Posted: May 14, 2009

Record last verified: 2009-05

Locations

US (1)