At a glance
ClinicalIndex Comparison Record- ✓Locally advanced or metastatic colorectal adenocarcinoma not curable by surgery or amenable to radiation therapy with curative intent
- ✓Histologically or cytologically confirmed disease with primary lesion in large bowel
- ✓Measurable or evaluable disease
- ✓ECOG performance status 0, 1, or 2
- ✕CNS metastases or carcinomatous meningitis
- ✕Prior exposure to both oxaliplatin AND irinotecan
- ✕Symptomatic sensory peripheral neuropathy
- ✕Uncontrolled diarrhea (>3 loose stools daily without colostomy/ileostomy)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Placebo and Pegfilgrastim for Colon Cancer and 2 related conditions. Completed, enrolled 252 participants.
Detailed Summary
The purpose of this research study is to evaluate the safety and effectiveness of pegfilgrastim in reducing grade 3/4 neutropenia when given after one of three chemotherapy regimens (FOIL, FOLFOX or FOLFIRI) in patients with locally advanced or metastatic colorectal cancer. This study is considered to be "investigational" because the time between receiving pegfilgrastim and the next cycle of chemotherapy is only 11 days.
Study Details
Timeline
Interventions
Subjects randomized to placebo will receive a 6 mg subcutaneous injection once per cycle at least 24 hours after completion of 5-FU chemotherapy infusion. Subjects will continue to receive one injection per cycle until completion of 4 cycles, or until early termination from the study treatment period, whichever occurs first.
Subjects randomized to pegfilgrastim will receive a 6 mg subcutaneous injection once per cycle at least 24 hours after completion of 5-FU chemotherapy infusion. Subjects will continue to receive one injection per cycle until completion of 4 cycles, or until early termination from the study treatment period, whichever occurs first.