A Phase 3 interventional study of bevacizumab and cetuximab in Colorectal Cancer, sponsored by Alliance for Clinical Trials in Oncology. Terminated at 2 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating mitomycin C to several degrees above normal body temperature and infusing it into the area around the tumor may kill more tumor cells. Giving mitomycin C after surgery may kill any remaining tumor cells. It is not yet known whether standard therapy is more effective with or without surgery followed by mitomycin C.
PURPOSE: This randomized phase III trial is studying standard therapy with or without surgery and mitomycin C in treating patients with advanced limited peritoneal dissemination of colon cancer
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to presentation (synchronous vs metachronous carcinomatosis), ECOG performance status (0 vs 1), disease volume (measurable vs non-measurable), prior first-line therapy for advanced disease (chemo-naïve vs prior first-line therapy), planned chemotherapy (oxaliplatin vs irinotecan vs fluorouracil/leucovorin calcium vs capecitabine), and planned biologic therapy (bevacizumab vs cetuximab vs none). Patients are randomized to 1 of 2 treatment arms.
NOTE: *For patients with KRAS wild-type tumors.
Blood and tissue samples may be collected from patients for correlative studies.
Patients complete SF-36 Health Survey; Functional Assessment of Cancer Therapy-Colorectal (FACT-C); Feeling Sad, Down, or Depressed (CES-D); and a Brief Pain Inventory quality-of-life questionnaires at baseline and then periodically during study.
After completion of study therapy, patients are followed up periodically for 5 years.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's planned enrollment of 340 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed colon adenocarcinoma meeting the following criteria:
Disease amenable to complete cytoreduction surgery as indicated by:
PATIENT CHARACTERISTICS:
INR ≤ 1.5
No history of severe congestive heart failure or severe pulmonary disease
PRIOR CONCURRENT THERAPY:
No prior second-line systemic treatment for metastatic colon adenocarcinoma
Patients receive standard systemic therapy, at the discretion of patients' oncologist, comprising combinations of fluorouracil, leucovorin calcium, irinotecan hydrochloride, oxaliplatin, and/or capecitabine (including FOLFOX4, mFOLFOX6, CapeOx, or FOLFIRI), bevacizumab, or cetuximab. Treatment repeats in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may crossover to arm II.
Biological: bevacizumab · Biological: cetuximab · Drug: FOLFIRI regimen · Drug: FOLFOX regimen · Drug: capecitabine · Drug: fluorouracil · Drug: irinotecan hydrochloride · Drug: leucovorin calcium · Drug: oxaliplatin
Patients undergo cytoreduction surgery and hyperthermic intraperitoneal mitomycin C over 45-90 minutes. Beginning 8 weeks after surgery, patients receive standard systemic therapy as in arm I. Treatment with systemic therapy repeats for 6 courses in the absence of disease progression or unacceptable toxicity.
Biological: bevacizumab · Biological: cetuximab · Drug: FOLFIRI regimen · Drug: FOLFOX regimen · Drug: capecitabine · Drug: fluorouracil · Drug: irinotecan hydrochloride · Drug: leucovorin calcium · Drug: mitomycin C · Drug: oxaliplatin · Procedure: therapeutic conventional surgery
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Given intraperitoneally
Given IV
Patients undergo cytoreductive surgery
Overall survival (OS)
Progression-free survival (PFS)
Quality of life
Toxicity burden
Circulating tumor cells
Comparison of OS and PFS according to patients' peritoneal surface tumor genotype for the NAD(P)H
This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology