Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00383331 |
Recruitment Status :
Terminated
(Trial was stopped early due to low enrollment)
First Posted : October 3, 2006
Results First Posted : May 14, 2009
Last Update Posted : June 3, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small-Cell Lung Cancer | Drug: Pemetrexed Drug: Gemcitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | January 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: A |
Drug: Pemetrexed
A: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles Other Names:
Drug: Gemcitabine A: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles Other Names:
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Experimental: B |
Drug: Pemetrexed
A: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles Other Names:
Drug: Gemcitabine A: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles Other Names:
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- Best Overall Tumor Response [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ]Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
- Progression Free Survival [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ]baseline to measured progressive disease
- Time to Progressive Disease [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ]Time to progressive disease not analyzed because trial was stopped early due to low enrollment.
- Duration of Response [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ]Duration of response was not analyzed because the trial was stopped early due to low enrollment.
- Time to Treatment Failure [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ]Time to treatment failure was not analyzed because the trial was stopped early due to low enrollment.
- Overall Survival [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ]Survival time is defined as the time from date of randomization to death due to any cause.

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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:
- histologic or cytologic diagnosis of NSCLC Stage IIIB or IV
- no prior systemic chemotherapy for advanced Non-Small Cell Lung Cancer
- Prior radiotherapy must be completed at least 4 weeks before study enrollment.
Exclusion Criteria:
- estimated life expectancy of 12 weeks
- a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
- documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 2 weeks before enrollment
- significant weight loss (that is, > 10%) over the previous 6 weeks before study entry.

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): NCT00383331
United States, Minnesota | |
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. | |
Rochester, Minnesota, United States, 55905 |
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: | NCT00383331 |
Other Study ID Numbers: |
9431 H3E-US-S061 |
First Posted: | October 3, 2006 Key Record Dates |
Results First Posted: | May 14, 2009 |
Last Update Posted: | June 3, 2009 |
Last Verified: | May 2009 |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Pemetrexed |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |