The purpose of this study is to find out how effective the new combination of the drugs
Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon
and rectal cancer. All three of these drugs are approved by the Food and Drug Administration
(FDA) for the treatment of colon or rectal cancer. This however is the first time that these
three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
Inclusion Criteria:
- Patients must have histological or cytological confirmed metastatic colorectal
cancer.
- 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 Cockroft-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
document.
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
events.
- 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
recovery.
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption
syndrome.
- History of clinically significant interstitial lung disease and/or pulmonary
fibrosis.
- History of persistent neurosensory disorder including but not limited to peripheral
neuropathy
- 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
