Chemotherapy and Radiotherapy to Treat Patients With Limited Stage of Small Cell Lung Cancer (SCLC)

NCT00494026 | Terminated Phase 2 Results DMC

• 2 other identifiers: 10015H3E-MC-S095
• Study Type: interventional
• Target: 4
• Locations: 4 countries
• Sites: 12

Brief Summary

This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed + carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell lung cancer

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR])

  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 response after chemotherapy and radiation

Secondary Outcomes (4)

• Progression-free Survival

  baseline to measured progressive disease

• Overall Survival

  baseline to date of death from any cause, 1 year

• Duration of Response

  time of response to progressive disease

• Pharmacology Toxicity

  every 21-day cycle for 4 cycles

Study Arms (1)

Pemetrexed + Carboplatin

EXPERIMENTAL

Drug: pemetrexed; Drug: carboplatin; Procedure: radiotherapy

Interventions

pemetrexed DRUG

500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles

Also known as: LY231514, Alimta

Pemetrexed + Carboplatin

carboplatin DRUG

Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles

Pemetrexed + Carboplatin

radiotherapy PROCEDURE

2 Gray (Gy) per fraction, 5 fractions per week, begin day 1, cycle 3 x 5 weeks (Monday-Friday)

Pemetrexed + Carboplatin

Eligibility Criteria

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

You may qualify if:

• Histologic and/or cytologic diagnosis of Limited Stage of small cell lung cancer
• Measurable disease
• Good performance status
• Adequate bone marrow reserve, hepatic, pulmonary and renal functions

You may not qualify if:

• Serious concomitant systemic disorder
• Prior chemotherapy for this cancer and/or prior thoracic radiotherapy
• Pregnancy/breast-feeding
• Significant weight loss over the previous 6 weeks before study entry
• Inability or unwillingness to take vitamin supplementation and corticosteroids

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (12)

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.

Orbassano, 10043, Italy

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.

Parma, 43100, Italy

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.

San Sisto, 06156, Italy

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.

Terni, 05100, Italy

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.

Poznan, 60-569, Poland

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.

Warsaw, 02-781, Poland

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.

Madrid, 28035, Spain

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.

Palma de Mallorca, 07014, Spain

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.

Valencia, 46010, Spain

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.

Southampton, Hants, SO16 6YD, United Kingdom

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.

Guildford, Surrey, GU2 7XX, United Kingdom

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.

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Pemetrexed; Carboplatin; Radiotherapy

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; Coordination Complexes; Organic Chemicals; Therapeutics

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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 27, 2007
• First Posted: June 29, 2007
• Study Start: September 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 20, 2009
• Results First Posted: November 17, 2009

Record last verified: 2009-11

Locations

IT (4); PL (2); ES (3); GB (3)