Know Cancer

or
forgot password

A Randomized, Multi-Center Phase III Trial Of Irinotecan In Combination With Three Different Methods Of Administration Of Fluoropyrimidine: Infusional 5-FU (FOLFIRI), Modified-Bolus 5-FU (Day 1 & 8), And Oral Capecitabine (Day 1-14); With Celecoxib Versus Placebo As First-Line Treatment For Patients With Metastatic Colorectal Cancer Study Amended April 23, 2004 To Include Bevacizumab


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms

Thank you

Trial Information

A Randomized, Multi-Center Phase III Trial Of Irinotecan In Combination With Three Different Methods Of Administration Of Fluoropyrimidine: Infusional 5-FU (FOLFIRI), Modified-Bolus 5-FU (Day 1 & 8), And Oral Capecitabine (Day 1-14); With Celecoxib Versus Placebo As First-Line Treatment For Patients With Metastatic Colorectal Cancer Study Amended April 23, 2004 To Include Bevacizumab


Inclusion Criteria:



- Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with
evidence of metastatic disease. (Stage IV distant disease)

- Present or past histological documentation of adenocarcinoma of the colon or rectum.
The site of the primary lesion must be or have been confirmed endoscopically,
radiologically, or surgically to be or have been in the large bowel. Patients with a
history of colorectal cancer treated by surgical resection who develop radiological
or clinical evidence of metastatic cancer do not require separate histological or
cytological confirmation of metastatic disease unless:

- An interval of greater than five years has elapsed between the primary surgery and
the development of metastatic disease.

- The primary cancer was a Duke's A or B1.

- Physicians should consider biopsy of lesions to establish the diagnosis of metastatic
colorectal cancer in each case if there is substantial clinical ambiguity regarding
the nature of source of apparent metastases.

Exclusion Criteria:

- Patients who received any prior systemic anticancer therapy for metastatic colorectal
cancer (e.g., chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine
therapy, cytokine therapy, or other experimental agents).

- Patients cannot have concurrent malignancies at study entry.

- Exceptions: Patients with prior non-colorectal malignancies will be eligible if
they have been disease-free for ³ 3 years or are deemed at low risk for recurrence by
their treating physician (e.g., early stage prostate cancer, melanoma or bladder
cancer). Patients with squamous or basal cell carcinoma of the skin or in situ
cervical cancer that have been effectively treated are eligible, even if these were
diagnosed within 3 years before randomization.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL

Outcome Time Frame:

every 6 weeks until disease progression

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Institutional Review Board

Study ID:

CPTAIV-0020-411

NCT ID:

NCT00101686

Start Date:

February 2003

Completion Date:

October 2008

Related Keywords:

  • Colorectal Neoplasms
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteSanta Fe, New Mexico  87505
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteBartlesville, Oklahoma  74006
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteShreveport, Louisiana  71103
Pfizer Investigational SiteMilwaukee, Wisconsin  53215
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteLivingston, New Jersey  07039
Pfizer Investigational SiteWashington, District of Columbia  20007-2197
Pfizer Investigational SiteBurlington, Vermont  05401-3456
Pfizer Investigational SiteBillings, Montana  59101
Pfizer Investigational SiteLebanon, New Hampshire  03766
Pfizer Investigational SiteBangor, Maine  04401