Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00101686 · ClinicalTrials.gov registry record · Phase 3
Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.
A Phase 3 study of Colorectal Neoplasms, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 547
- Enrollment target
- 20
- Study locations
NCT00101686: Completed Phase 3 study of Colorectal Neoplasms, sponsored by Pfizer.
NCT00101686 is a Phase 3 study of Colorectal Neoplasms that has completed, run by Pfizer. The registered enrollment target is 547 participants, roughly in line with the 566-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00101686, a Phase 3 study of Colorectal Neoplasms, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 547 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study compares in the first study period combination of Irinotecan with three different methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second period of study it compares FOLFIRI \[a chemotherapy regime that combines bolus irinotecan and leucovorin \[LV\] with infusional 5-fluorouracil (5-FU)\] + bevacizumab and mlFL + bevacizumab. Measures of efficacy and safety will be reported.
Primary Outcome
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
Conditions Studied
Interventions
- DRUG Modified Bolus 5-FU/LV with Irinotecan
- DRUG FOLFIRI + bevacizumab
- DRUG miFL + bevacizumab
- DRUG Infusional 5-FU/LV with Irinotecan
- DRUG Oral Capecitabine with Irinotecan
Study Locations (20)
California
- Pfizer Investigational Site - Arroyo Grande
- Pfizer Investigational Site - Fountian Valley
- Pfizer Investigational Site - Fresno
- Pfizer Investigational Site - Los Gatos
- Pfizer Investigational Site - Mission Hills
- Pfizer Investigational Site - Modesto
- Pfizer Investigational Site - Orange
- Pfizer Investigational Site - Oxnard
- Pfizer Investigational Site - San Diego
- Pfizer Investigational Site - San Jose
Alabama
- Pfizer Investigational Site - Birmgingham
- Pfizer Investigational Site - Birmingham
- Pfizer Investigational Site - Birmngham
- Pfizer Investigational Site - Mobile
Arizona
- Pfizer Investigational Site - Flagstaff
- Pfizer Investigational Site - Sedona
- Pfizer Investigational Site - Tucson
Arkansas
- Pfizer Investigational Site - Hot Spring
- Pfizer Investigational Site - Springdale
Colorado
- Pfizer Investigational Site - Boulder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 547 participants |
| Start Date | 2003-02 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00101686 record still lists
NCT00101686 is an interventional study that assigns participants to a tested intervention. The registered 547 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 566-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target.
The record links to 1 condition, with Colorectal Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Modified Bolus 5-FU/LV with Irinotecan is the first listed.
NCT00101686 names 20 study sites across 5 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00101686 about?
NCT00101686 is a clinical study titled "Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.". This study compares in the first study period combination of Irinotecan with three different methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second period of study it compares FOLFIRI \[a chemotherapy regime that combines bolus irinotecan and leucovorin \[LV\] w...
What is the current status of trial NCT00101686?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 547 participants. The study started on 2003-02. Estimated completion is 2008-10.
What conditions does trial NCT00101686 study?
This clinical trial studies the following conditions: Colorectal Neoplasms.
What interventions are being tested in trial NCT00101686?
The interventions under investigation include: Modified Bolus 5-FU/LV with Irinotecan (DRUG), FOLFIRI + bevacizumab (DRUG), miFL + bevacizumab (DRUG), Infusional 5-FU/LV with Irinotecan (DRUG), Oral Capecitabine with Irinotecan (DRUG).
Who is sponsoring clinical trial NCT00101686?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00101686 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00101686's enrollment target sits among peer trials
547 13th of 54 higher than 42 of 54 other Colorectal Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
RECRUITING · Phase 3
-
A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
RECRUITING · Phase 3
-
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
RECRUITING · Phase 3
-
A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer
RECRUITING · Phase 3
-
A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer
RECRUITING · Phase 3
-
S0820, Adenoma and Second Primary Prevention Trial
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03572374 · 546 participants · NA
Talking to Employers and Medical Staff About Breast Cancer Treatment and Your Job
- NCT05937685 · 546 participants · NA
Reducing Blood Pressure in Patients With High Cardiovascular Risk
- NCT06416150 · 546 participants · NA
Reducing Urban Cervical Cancer Disparities
- NCT06850922 · 546 participants · Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia