A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy
This study has been terminated.
(Interim results of another trial showed inferior activity of treatment)
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00447421
First received: March 12, 2007
Last updated: October 24, 2009
Last verified: October 2009
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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:
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:
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 |
| 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
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:
No publications provided
| 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:
|
Carcinoma, Small Cell Lung Neoplasms Small Cell Lung Carcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms |
Thoracic Neoplasms Cisplatin Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015