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A Phase II Study of Capecitabine in Combination With Irinotecan and Oxaliplatin (Eloxatin) in Adult Patients With Advanced Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

A Phase II Study of Capecitabine in Combination With Irinotecan and Oxaliplatin (Eloxatin) in Adult Patients With Advanced Colorectal Cancer

The primary objective of the study is to determine the radiographic response rate in
patients with metastatic colorectal cancer treated with Oxaliplatin, Capecitabine and
Irinotecan. Secondary objectives are to determine the time to tumor progression and the
toxicity and tolerability of Oxaliplatin, Capecitabine and Irinotecan when administered in
combination. Study schema is as follows. Cycles are 42 days long. Patients will receive
Oxaliplatin and Capecitabine on day 1. Capecitabine is an oral pill that will be taken for
14 days. Patients return again on day 21 when they receive Irinotecan and Capecitabine.
Capecitabine again is taken for 14 days. CT scans are performed at the end of the 6 week
cycle to determine response.

Inclusion Criteria:

- Patients must have histological or cytological confirmed metastatic colorectal

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as
>20 mm with conventional techniques or as >10 mm with spiral CT scan.

- No prior chemotherapy in the metastatic setting (prior fluorouracil chemotherapy, if
administered in the adjuvant setting, and if more than 6 months has passed since the
completion of therapy, is allowable). Prior adjuvant radiation therapy allowable
provided no greater than 30% total bone marrow included in the field (must be more
than 6 weeks since completion of radiation therapy.

- Subject must be 18 years or older

- Life expectancy greater than 12 weeks.

- ECOG performance status <2 (Karnofsky >60%).

- Patients must have normal organ and marrow function as defined as: leukocytes
>3,000/mcL; absolute neutrophil count >1,500/mcL; Platelets >100,000/mcL; total
bilirubin within normal institutional limits; AST(SGOT)/ALT (SGPT) <2.5 X
institutional upper limit of normal; Creatinine within normal institutional limits
and Creatinine clearance (estimated by Cockcroft-Gault equation)>50-mL/min/1.73 m2
for patients with creatinine levels above institutional normal

- Has a negative serum or urine pregnancy test within 7 days prior to initiation of
therapy (female patients of childbearing potential).

- Woman of childbearing potential with either a positive or no pregnancy test at
baseline. (Postmenopausal woman must have been amenorrheic for at least 12 months to
be considered of non-childbearing potential). Patients will agree to continue
contraception for 30 days from the date of the last study drug administration

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Prior therapy for MCRC in the metastatic setting.

- Patients may not be receiving any other investigational agents.

- Patients with known brain metastases will be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse

- Grade 2 or greater peripheral neuropathy.

- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity
to 5-fluorouracil.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements. Clinically significant cardiac disease (e.g. congestive heart
failure, symptomatic coronary artery disease and cardiac arrhythmias not well
controlled with medication) or myocardial infarction within the last 12 months.

- Pregnant and nursing women are excluded from this study. Women / men of childbearing
potential not using a reliable and appropriate contraceptive method.

- Because patients with immune deficiency are at increased risk of lethal infections
when treated with marrow-suppressive therapy, HIV-positive patients receiving
combination anti-retroviral therapy are excluded from the study because of possible
pharmacokinetic interactions with Oxaliplatin and Irinotecan or other agents
administered during the study.

- Major surgery within 4 weeks of the start of study treatment, without complete

- Lack of physical integrity of the upper gastrointestinal tract or malabsorption

- History of clinically significant interstitial lung disease and/or pulmonary

- History of persistent neurosensory disorder including but not limited to peripheral

- Treatment for other carcinomas within the last five years, except cured non-melanoma
skin and treated in-situ cervical cancer.

- Participation in any investigational drug study within 4 weeks preceding the start of
study treatment.

- Any prior platinum based therapy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Description:

To determine the radiographic response rate in patients with metastatic colorectal cancer treated with Oxaliplatin, Capecitabine and Irinotecan

Outcome Time Frame:

average of 12 months

Safety Issue:


Principal Investigator

Christopher Garrett, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center & Research Institute (now at M.D. Anderson)


United States: Food and Drug Administration

Study ID:




Start Date:

December 2004

Completion Date:

July 2007

Related Keywords:

  • Colorectal Cancer
  • advanced
  • colon
  • rectal
  • Colorectal Neoplasms



H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612