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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00079872




Registration number
NCT00079872
Ethics application status
Date submitted
17/03/2004
Date registered
19/03/2004
Date last updated
6/11/2007

Titles & IDs
Public title
Pemetrexed Plus a Comparator Versus a Combination of 2 Comparators in First-Line Treatment of Colorectal Cancer
Scientific title
A Randomized Phase 2 Trial of ALIMTA Plus a Comparator Versus Leucovorin Modulated Fluorouracil Plus a Comparator in First Line Treatment of Locally Advanced or Metastatic Colorectal Cancer
Secondary ID [1] 0 0
H3E-MC-JMAZ
Secondary ID [2] 0 0
2929
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective is to compare the antitumor activity of pemetrexed plus a comparator with that of leucovorin modulated 5 FU plus a comparator as measured by tumor response rate for patients with locally advanced or metastatic colorectal cancer
Timepoint [1] 0 0
Secondary outcome [1] 0 0
The secondary objectives of the study are as follows:
Timepoint [1] 0 0
Secondary outcome [2] 0 0
to assess the following time to event efficacy endpoints for patients in both treatment arms:
Timepoint [2] 0 0
Secondary outcome [3] 0 0
overall survival
Timepoint [3] 0 0
Secondary outcome [4] 0 0
progression free survival
Timepoint [4] 0 0
Secondary outcome [5] 0 0
duration of response
Timepoint [5] 0 0
Secondary outcome [6] 0 0
to characterize the quantitative and qualitative toxicities of both treatment arms in this patient population
Timepoint [6] 0 0

Eligibility
Key inclusion criteria
The patient must have:

* Histologic or cytologic diagnosis of adenocarcinoma of the colon or rectum.
* Performance status of 0 to 2 on the ECOG Performance Status Scale.
* Standard postoperative adjuvant radiation therapy for rectal cancer is allowed.
* Locally advanced or metastatic disease.
* Must be 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patient must not have:

* Received prior chemotherapy for advanced disease. Prior adjuvant therapy, including 5-FU, is allowed if it has been more than 12 months since the last treatment.
* Received prior treatment with irinotecan in the adjuvant setting.
* Are unable to take vitamin B12 or folic acid.
* Are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs, or COX-2 inhibitors for a 5-day period.
* Have a second primary malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician - NSW, QLD, South Australia
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician - Woodville
Recruitment postcode(s) [1] 0 0
- NSW, QLD, South Australia
Recruitment postcode(s) [2] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Frankfurt/Main
Country [2] 0 0
Greece
State/province [2] 0 0
Krete
Country [3] 0 0
Netherlands
State/province [3] 0 0
Amsterdam
Country [4] 0 0
Spain
State/province [4] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
In this study, patients will receive either pemetrexed plus irinotecan or 5-fluorouracil (5-FU), leucovorin, and irinotecan.

The purposes of this study are to determine:

* How pemetrexed plus irinotecan compares with 5-FU, leucovorin, and irinotecan in terms of efficacy.
* The safety of pemetrexed plus irinotecan and any side effects that might be associated with it as compared with 5-FU, leucovorin, and irinotecan.
* Whether pemetrexed can help patients with colorectal cancer.
Trial website
https://clinicaltrials.gov/study/NCT00079872
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00079872