Chemotherapy Administered Every 2 Weeks With or Without a Single Injection of Pegfilgrastim as First or Second-Line Treatment in Subjects With Locally Advanced or Metastatic Colon Cancer
- Locally advanced or metastatic colorectal adenocarcinoma not curable by surgery or
amenable to radiation therapy with curative intent.
- Histologically or cytologically documented locally advanced or metastatic colorectal
cancer. The site of the primary lesion must be or has been confirmed endoscopically,
radiologically, or surgically to be or has been in the large bowel.
- Measurable or evaluable disease.
- ECOG performance status 0, 1 or 2
- Life expectancy ≥ 12 weeks
- All of the following: (1) ≥ 4 weeks must have elapsed from the time of major surgery
and subjects must have recovered from the effects (e.g., laparotomy); (2) ≥ 2 weeks
must have elapsed from the time of minor surgery and subjects must have recovered
from the operation (insertion of a vascular access device is not considered major or
minor surgery); (3) ≥ 4 weeks must have elapsed from the time of major radiotherapy
(e.g., chest or bone palliative radiation therapy).
- Subjects may have received prior adjuvant therapy and one prior chemotherapy regimen
for metastatic disease providing 30 days has elapsed from last chemotherapy dose.
- Subject must have recovered from prior chemotherapy complications and in the opinion
of the investigator, the subjects current status does not place the subject at risk
for entry into the trial.
- Subjects with prior exposure to both oxaliplatin and irinotecan will not be eligible
to participate in this study. However, if subject received prior therapy with
oxaliplatin, they will be eligible to receive the FOLFIRI regimen. If subject
received prior therapy with irinotecan, they will be eligible to receive the FOLFOX
- Age ≥ 18 years
- Absolute neutrophil count ≥ 1.5 x 109/L
- Platelet count ≥100 x 109/L
- Hemoglobin ≥ 9.0 g/dL (subjects may be receive a red blood cell transfusion to
achieve this requirement)
- Creatinine ≤ 1.5 x UNL
- Total bilirubin ≤ 1.5 mg/dL (≤ 25.65 μmol/L), regardless of whether subjects have
liver involvement secondary to tumor
- Aspartate aminotransferase ≤ 5 x UNL
- Alkaline phosphatase ≤ 5 x UNL
- Informed consent to participate on the study.
- Standard chemoradiation as adjuvant treatment for colorectal cancer will be allowed,
but prior radiotherapy to >15% of bone marrow or outside of standard adjuvant
colorectal cancer chemoradiation is not allowed.
- Known central nervous system metastases or carcinomatous meningitis.
- Predisposing colonic or small bowel disorders in which the symptoms are uncontrolled
as indicated by baseline pattern of >3 loose stools daily in subjects without a
colostomy or ileostomy. Subjects with a colostomy or ileostomy may be entered at the
- Pleural effusion or ascites, which cause respiratory compromise (≥Grade 2 dyspnea).
- Concurrent use of other investigational agents.
- No active infection requiring the start of systemic (intravenous or oral)
anti-infective (antibiotic, antifungal, antiviral) within 72 hours of the
administration of the first cycle of study chemotherapy.
- Symptomatic sensory peripheral neuropathy.
- The following conditions: Uncontrolled high blood pressure; unstable angina;
symptomatic congestive heart failure; myocardial infarction ≤ 6 months prior to
randomization; serious uncontrolled cardiac arrhythmia; New York Heart Association
classification III or IV.
- Prior malignancy, except for adequately treated basal cell or squamous cell skin
cancer, adequately treated noninvasive carcinomas, or other cancer from which the
patient has been disease-free for at least five years.
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the
- Medical or psychiatric conditions which, in the opinion of the Investigator, make
participation in an investigational trial of this nature a poor risk.
- Known sensitivity to E. coli derived products (e.g., Filgrastim, HUMULIN® insulin,
L-asparaginase, HUMATROPE® Growth Hormone, INTRON® A) or known sensitivity to any of
the products to be administered during dosing.
- Subject is currently enrolled or has not yet completed at least 30 days since ending
other investigational device or drug trial(s) or is receiving other investigational
- Subject of child-bearing potential is evidently pregnant (e.g., positive HCG test) or
is breast feeding.
- Subject is not using adequate contraceptive precautions.
- Subject will not be available for follow-up assessment.
- Concerns for subject's compliance with the protocol procedures.