Back to resultsA Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.
Primary Purpose
Rectal Neoplasms
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Neoplasms
Eligibility Criteria
Inclusion Criteria: no prior therapy for rectal cancer pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to surgery. adequate organ function Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1 signed informed consent at least 18 years of age surgically sterile, postmenopausal (women) or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment. Exclusion Criteria: concurrent administration of any other anti-tumor therapy treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry serious concomitant systemic disorders previously completed or withdrawn from this study pregnant or breast-feeding second primary malignancy history of significant neurological or mental disorder, including seizures or dementia inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs) presence of clinically relevant third space fluid collections that cannot be controlled by drainage or other procedure prior to the study entry inability or unwillingness to take folic acid, vitamin B12 or dexamethasone
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of Pemetrexed Prior to Surgery
Feasibility was defined as the ability to receive the total planned dose of Pemetrexed administered over a period of no more than 9 weeks permitting scheduling conflict. A ±5 percent variance in the calculated total dose was allowed.
Secondary Outcome Measures
Pathological Complete Response (pCR)
Pathological complete response was defined as the absence of any tumor cells.
Number of Participants With Complete Tumor Resection
Number of Participants Receiving Sphincter Saving Surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00330915
Brief Title
A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.
Official Title
A Feasibility Study of Pemetrexed Single Agent and Folic Acid Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to help answer the following research questions:
If the study drug Pemetrexed can help patients with rectal cancer; If molecular biological parameters are correlated respectively changing due to cytotoxic treatment with Pemetrexed; To evaluate adverse events
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Other Intervention Name(s)
LY231514, Alimta
Intervention Description
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
Primary Outcome Measure Information:
Title
Feasibility of Pemetrexed Prior to Surgery
Description
Feasibility was defined as the ability to receive the total planned dose of Pemetrexed administered over a period of no more than 9 weeks permitting scheduling conflict. A ±5 percent variance in the calculated total dose was allowed.
Time Frame
3 cycles (21-day cycles)
Secondary Outcome Measure Information:
Title
Pathological Complete Response (pCR)
Description
Pathological complete response was defined as the absence of any tumor cells.
Time Frame
surgery following 3 cycles (21-day cycles) of chemotherapy
Title
Number of Participants With Complete Tumor Resection
Time Frame
surgery following 3 cycles (21-day cycles) of chemotherapy
Title
Number of Participants Receiving Sphincter Saving Surgery
Time Frame
surgery following 3 cycles (21-day cycles) of chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
no prior therapy for rectal cancer
pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to surgery.
adequate organ function
Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
signed informed consent
at least 18 years of age
surgically sterile, postmenopausal (women) or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment.
Exclusion Criteria:
concurrent administration of any other anti-tumor therapy
treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
serious concomitant systemic disorders
previously completed or withdrawn from this study
pregnant or breast-feeding
second primary malignancy
history of significant neurological or mental disorder, including seizures or dementia
inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs)
presence of clinically relevant third space fluid collections that cannot be controlled by drainage or other procedure prior to the study entry
inability or unwillingness to take folic acid, vitamin B12 or dexamethasone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/ GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Göteborg
ZIP/Postal Code
41685
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.
We'll reach out to this number within 24 hrs