A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Gemcitabine; avastin; 5FU/folinic acid; oxaliplatin
Intervention description: 900 mg/m2 IV over 90 minutes after Folinic Acid weekly for 6 weeks every 8 weeks until progression.; 5 milligrams per kilogram (mg/kg); Folinic Acid: 100 milligrams per square meter (mg/m2) intravenous (IV) over 60 minutes (A+FFG).
Folinic Acid: 200 mg/m2 as a 2-hr infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4).
5-Fluorouracil: 450 mg/m2 as an IV bolus in middle of Folinic Acid (A+FFG). 5-Fluorouracil: 400 mg/m2 bolus plus a 600 mg/m2 22-hour infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4).; 85 mg/m2 as a 2-hour infusion on Day 1 of a 14 day cycle.
Intervention MeSH terms: Leucovorin; Folic Acid; Gemcitabine; Oxaliplatin; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to describe the tumor response rates for the two regimens being
      studied, and to determine how long patients live after receiving the treatment, how long
      patients are without return of their disease after they receive treatment, and how long the
      response they get from the treatment lasts. The amount and type of side effects/toxicities of
      each regimen will also be evaluated. The regimen including Oxaliplatin + 5FU/Folinic Acid is
      a current standard of care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a histological or cytological diagnosis of the colon or rectum with
             Stage III unresectable or Stage IV disease.

          -  Urinalysis or Urine dipstick for proteinuria of less than 1+ (i.e. either 0 or trace).
             If urine dipstick is greater than 1+, the 24 hour urine protein must demonstrate less
             than 500 mg of protein in 24 hours to allow participation.

          -  No prior chemotherapy, immunotherapy, or hormonal treatment for metastatic disease is
             acceptable. However, one prior neo-adjuvant or adjuvant treatment is acceptable,
             including Capecitabine, Camptothecin-11 (CPT-11), 5 Fluorouracil/Leucovorin (5FU/LV)
             or Radiation containing regimens, (but no Oxaliplatin), and only if progression > 6
             months since last adjuvant treatment.

          -  Prior radiation therapy, including radiation to the whole pelvis, is allowed (Cristy
             and Eckerman 1987) and patients must have recovered from the acute toxic effects of
             the treatment prior to study enrollment. Prior palliative radiation therapy given to a
             non-measurable diagnostic site is acceptable if given > 4 weeks prior to treatment or
             if other non-irradiated measurable disease is present.

          -  No known central nervous system (CNS) metastasis.

        Exclusion Criteria:

          -  Histology other than adenocarcinoma

          -  Tumors that demonstrate free perforation as manifested by free air or free fluid in
             the abdomen. Patients with walled-off perforation are eligible.

          -  Gastroduodenal ulcer determined as active by endoscopy.

          -  Invasive procedures defined as follows; major surgical procedures, open biopsy, or
             significant traumatic injury within 28 days prior to randomization, anticipation of
             need for major surgical procedure during the course of study, core biopsy or other
             minor procedure within 7 days prior to registration.

          -  Following cardiac condition; New York Heart Association (NYHA) Class III or IV,
             myocardial infarction (MI) within 6 months, unstable angina within 6 months and
             current symptomatic arrhythmia.