Combination Chemotherapy and Bevacizumab With or Without RO4929097 in Treating Patients With Metastatic Colorectal Cancer

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01270438
Phase
PHASE2
Status
Withdrawn

Conditions

  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FOLFOX regimen — DRUG
    Given IV
  • gamma-secretase/Notch signalling pathway inhibitor RO4929097 — DRUG
    Given orally
  • bevacizumab — BIOLOGICAL
    Given IV
  • oxaliplatin — DRUG
    Given IV
  • leucovorin calcium — DRUG
    Given IV
  • fluorouracil — DRUG
    Given IV

Study Details

This phase II clinical trial is studying how well giving combination chemotherapy and bevacizumab with or without RO4929097 works in treating patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy and bevacizumab is more effective with RO4929097 in treating patients with colorectal cancer.

Key Dates

First listed
Jan 5, 2011
Start date
Dec 31, 2010
Status verified
Apr 2017
Primary completion
Aug 31, 2011
Completion
Aug 31, 2013

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (RO4929097, combination chemotherapy, bevacizumab)
    Patients receive FOLFOX6 regimen comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46 hours, and bevacizumab IV over 30-90 minutes on days 1-2. Patients also receive oral gamma-secretase inhibitor RO4929097 on days 1-3 and 8-10. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (combination chemotherapy, bevacizumab)
    Patients receive FOLFOX6 regimen and bevacizumab as in arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free survival of patients treated with FOLFOX6 plus bevacizumab with or without gamma-secretase inhibitor RO4929097 [ Time Frame: From start of treatment to time of progression, assessed up to 12 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbusOhio43210-

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MNMemorial Sloan Kettering Cancer Center· New York, NYArthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center· Columbus, OH

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