At a glance
ClinicalIndex Comparison Record- ✓Histological or cytological diagnosis of colon or rectum cancer with Stage III unresectable or Stage IV disease
- ✓Urine protein <1+ on dipstick, or if ≥1+, then 24-hour urine protein <500 mg
- ✓No prior chemotherapy for metastatic disease; one prior adjuvant regimen allowed if progression >6 months since last treatment (Capecitabine, CPT-11, 5FU/LV, or radiation allowed, but not oxaliplatin)
- ✓Prior radiation therapy allowed; must have recovered from acute toxic effects. Palliative radiation to non-measurable sites acceptable if >4 weeks prior or other non-irradiated measurable disease present
- ✕Histology other than adenocarcinoma
- ✕Tumors with free perforation (free air or fluid in abdomen); walled-off perforation allowed
- ✕Active gastroduodenal ulcer on endoscopy
- ✕Major surgical procedure, open biopsy, or significant traumatic injury within 28 days; core biopsy or minor procedure within 7 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized Phase II Trial of Avastin Plus Gemcitabine Plus 5FU/Folinic Acid (A + FFG) vs. Avastin Plus Oxaliplatin Plus 5FU/Folinic Acid (A + FOLFOX 4) as Therapy for Patients With Metastatic Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating Gemcitabine, avastin, and 2 other interventions for Colorectal Cancer. Completed, enrolled 84 participants across 15 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.