A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy

NCT00447421 | Terminated Phase 1 Results

• 2 other identifiers: 11089H3E-EW-S107
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 4

Brief Summary

The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and radiotherapy in the treatment of patients with Small Cell Lung Cancer.

Conditions

Small Cell Lung Cancer; Carcinoma, Small Cell; SCLC

Outcome Measures

Primary Outcomes (2)

• Phase 1: Maximum Tolerated Dose

  every cycle

• Phase 2: Overall Response Rate

  Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.

  baseline to measured progressive disease

Secondary Outcomes (5)

• Phase 1: Best Overall Response

  baseline to measured response

• Phase 2: Complete Response Rate

  baseline to measured response time

• Phase 2: Time to Progressive Disease

  baseline to measured progressive disease

• Phase 2: Duration of Response

  time of response to progressive disease

• Phase 2: Overall Survival

  baseline to date of death from any cause

Study Arms (1)

A

EXPERIMENTAL

Drug: pemetrexed; Drug: cisplatin; Radiation: radiation

Interventions

pemetrexed DRUG

Phase 1: 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation) Phase 2: 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles

Also known as: LY231514, Alimta

A

cisplatin DRUG

Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles

A

radiation RADIATION

Phase 1 and Phase 2: 50-62 Gy, 25-31 days, cycles 2-4

A

Eligibility Criteria

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

You may qualify if:

• Measurable disease with diagnosis of Small Cell Lung Cancer.
• Performance status of 0 to 1 on the Eastern Cooperative Oncology Group performance status schedule.
• Patients must be at least 18 years of age and have at least a 12-week life expectancy.
• No prior chemotherapy and/or prior thoracic radiotherapy.
• Adequate pulmonary function and organ function.

You may not qualify if:

• Patients with myocardial infarction within the preceding six months.
• Diagnosis of a serious concomitant systemic disorder.
• Prior radiotherapy to the lower neck or abdominal region.
• Significant weight loss.
• Concurrent administration of any other antitumor therapy.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

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.

Leuven, 3000, Belgium

Location

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.

's-Hertogenbosch, 5211 NL, Netherlands

Location

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.

Amsterdam, 1081 HV, Netherlands

Location

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.

Rotterdam, 3075 EA, Netherlands

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Small Cell

Interventions

Pemetrexed; Cisplatin; Radiation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena

Limitations and Caveats

The Study Phase 1 was stopped early based on interim results of another trial, showing inferior activity of pemetrexed/carboplatin compared to etoposide/carboplatin in extensive small cell lung cancer. The Study did not progress to Phase 2.

Results Point of Contact

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

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 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 14, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: October 28, 2009
• Results First Posted: August 26, 2009

Record last verified: 2009-10

Locations

BE (1); NL (3)