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

Purpose

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.

Condition	Intervention	Phase
Small Cell Lung Cancer Carcinoma, Small Cell SCLC	Drug: pemetrexed Drug: cisplatin Radiation: radiation	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Cisplatin Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Phase 1: Maximum Tolerated Dose [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Phase 2: Overall Response Rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Phase 1: Best Overall Response [ Time Frame: baseline to measured response ] [ Designated as safety issue: No ]
Phase 2: Complete Response Rate [ Time Frame: baseline to measured response time ] [ Designated as safety issue: No ]
Phase 2: Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Phase 2: Duration of Response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
Phase 2: Overall Survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]


Enrollment:	9
Study Start Date:	February 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	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 Other Names: LY231514 Alimta Drug: 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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447421

Locations


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, Belgium, 3000
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, 1081 HV
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, 5211 NL
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, Netherlands, 3075 EA

Sponsors and Collaborators

Eli Lilly and Company

Investigators


Study Director:	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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site


Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00447421 History of Changes
Other Study ID Numbers:	11089 H3E-EW-S107
Study First Received:	March 12, 2007
Results First Received:	May 28, 2009
Last Updated:	October 24, 2009
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:


Lung Neoplasms Small Cell Lung Carcinoma Carcinoma, Small Cell Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms	Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Cisplatin Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 28, 2016