A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer
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| ClinicalTrials.gov Identifier: NCT00191984 |
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Recruitment Status :
Completed
First Posted : September 19, 2005
Results First Posted : June 15, 2009
Last Update Posted : January 5, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Colorectal Cancer | Drug: pemetrexed Drug: irinotecan | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 46 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Open Multicenter Phase II Study in Second-Line Metastatic Colorectal Cancer Patients: Combination of ALIMTA and Irinotecan Administered Every Two-Weeks |
| Study Start Date : | June 2004 |
| Actual Primary Completion Date : | February 2007 |
| Actual Study Completion Date : | May 2008 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Pemetrexed + Irinotecan |
Drug: pemetrexed
400 mg/m^2, intravenous (IV), every 14 days x 12 cycles
Other Names:
Drug: irinotecan 180 mg/m^2, intravenous (IV), every 14 days x 12 cycles |
- Best Overall Tumor Response [ Time Frame: baseline to measured progressive disease (up to 2 years 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.
Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.
Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria.
- Duration of Response [ Time Frame: time of response to progressive disease or death (up to 2 years follow-up) ]
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. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.
- Progression-Free Survival (PFS) [ Time Frame: baseline to measured progressive disease or death (up to 2 years follow-up) ]Defined as the time from study enrollment to the first date of disease progression or death as a result of any cause. PFS was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed.
- Time to Treatment Failure [ Time Frame: baseline to stopping treatment (up to 2 years follow-up) ]Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
- Overall Survival [ Time Frame: baseline to date of death from any cause (up to 2 years follow-up) ]Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of metastatic colorectal adenocarcinoma that is not amenable to curative therapy.
- Patient must have at least one unidimensionally measurable lesion.
- Prior radiation therapy to less than 25% of bone marrow. Radiation must be completed at least 4 weeks prior to study enrollment.
- Performance status 0 to 2
- Patient must have received 1 prior course of chemotherapy (Folfox regimen) for metastatic disease
Exclusion Criteria:
- Treatment with any drug within the last 30 days that has not received regulatory approval.
- Serious systemic disorder (cardiac or pulmonary disease, active infection)
- Documented brain metastases not amenable to surgery or unstable after radiation
- Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
- Presence of fluid retention that can not be controlled by drainage.
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): NCT00191984
| France | |
| 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. | |
| Angers, France | |
| 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. | |
| Lille, France | |
| 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. | |
| Montfermeil, France | |
| 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. | |
| Paris, France | |
| 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. | |
| Suresnes, France | |
| 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 |
Publications of Results:
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00191984 |
| Other Study ID Numbers: |
8673 H3E-FP-S057 ( Other Identifier: Eli Lilly and Company ) |
| First Posted: | September 19, 2005 Key Record Dates |
| Results First Posted: | June 15, 2009 |
| Last Update Posted: | January 5, 2011 |
| Last Verified: | January 2011 |
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Irinotecan Pemetrexed Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |