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

Small Cell Lung Cancer Clinical Trial

Official title:

Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00447421
• Other study ID #: 11089
• Secondary ID: H3E-EW-S107
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: March 12, 2007
• Last updated: October 24, 2009
• Start date: February 2007
• Est. completion date: May 2008

Study information

• Verified date: October 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Small Cell
• Lung Neoplasms
• SCLC
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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

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

Locations

Country	Name	City	State
Belgium	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
Netherlands	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
Netherlands	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.	Den Bosch
Netherlands	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Maximum Tolerated Dose		every cycle	Yes
Primary	Phase 2: Overall Response Rate		baseline to measured progressive disease	No
Secondary	Phase 1: Best Overall Response		baseline to measured response	No
Secondary	Phase 2: Complete Response Rate		baseline to measured response time	No
Secondary	Phase 2: Time to Progressive Disease		baseline to measured progressive disease	No
Secondary	Phase 2: Duration of Response		time of response to progressive disease	No
Secondary	Phase 2: Overall Survival		baseline to date of death from any cause	Yes

External Links

•   Lilly Clinical Trial Registry