A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy
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ClinicalTrials.gov Identifier: NCT00447421 |
Recruitment Status :
Terminated
(Interim results of another trial showed inferior activity of treatment)
First Posted : March 14, 2007
Results First Posted : August 26, 2009
Last Update Posted : October 28, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Small Cell Lung Cancer Carcinoma, Small Cell SCLC | Drug: pemetrexed Drug: cisplatin Radiation: radiation | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | May 2008 |
Actual Study Completion Date : | May 2008 |

Arm | Intervention/treatment |
---|---|
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 |
- Phase 1: Maximum Tolerated Dose [ Time Frame: every cycle ]
- Phase 2: Overall Response Rate [ Time Frame: baseline to measured progressive disease ]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.
- Phase 1: Best Overall Response [ Time Frame: baseline to measured response ]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; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
- Phase 2: Complete Response Rate [ Time Frame: baseline to measured response time ]Complete Response Rate was defined as the proportion of participants having a Complete Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions.
- Phase 2: Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ]Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
- Phase 2: Duration of Response [ Time Frame: time of response to progressive disease ]The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
- Phase 2: Overall Survival [ Time Frame: baseline to date of death from any cause ]Overall survival was the duration from enrollment to death. For patients who were alive, overall survival was censored at the last contact.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447421
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 |
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 |
Responsible Party: | Chief Medical Officer, Eli Lilly |
ClinicalTrials.gov Identifier: | NCT00447421 |
Other Study ID Numbers: |
11089 H3E-EW-S107 |
First Posted: | March 14, 2007 Key Record Dates |
Results First Posted: | August 26, 2009 |
Last Update Posted: | October 28, 2009 |
Last Verified: | October 2009 |
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 Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |