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Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.

Last updated on February 23, 2019

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Study Location
Pfizer Investigational Site
Birmgingham, Alabama, 35205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00101686
Pfizer
Completed
Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now