Clinical trial NCT00447421: A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy
Official title: Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Small Cell Lung Cancer
Carcinoma, Small Cell
SCLC
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-03-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Phase 1: Maximum Tolerated Dose
timeFrame: every cycle
measure: Phase 2: Overall Response Rate
timeFrame: baseline to measured progressive disease
Secondary outcomes:
measure: Phase 1: Best Overall Response
timeFrame: baseline to measured response
measure: Phase 2: Complete Response Rate
timeFrame: baseline to measured response time
measure: Phase 2: Time to Progressive Disease
timeFrame: baseline to measured progressive disease
measure: Phase 2: Duration of Response
timeFrame: time of response to progressive disease
measure: Phase 2: Overall Survival
timeFrame: baseline to date of death from any cause
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: 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.
city: Amsterdam
country: Netherlands
facility: 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.
city: Den Bosch
country: Netherlands
facility: 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.
city: Rotterdam
country: Netherlands
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: