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

Withdrawn before enrolling · Phase 2

Conditions studied: 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

In brief

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 facts

Study ID

NCT01270438

Run by

National Cancer Institute (NCI)

People needed

0

Starts

2010-12-01

Expected to finish

2013-08-01

Last updated by the study team

2017-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the colon or adenocarcinoma of the rectum
• Metastatic disease by imaging
• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20mm by conventional techniques or as ≥ 10 mm by spiral CT scan
• No known brain metastases
• ECOG performance status 0-1
• ANC ≥ 1,500/mm³
• WBC ≥ 3,000/mm³
• Platelet count ≥ 100,000/mm³ (without a platelet transfusion ≤ 14 days prior to study)
• Hemoglobin ≥ 9 g/dL
• Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
• Urine protein:creatinine ≤ 0.5 or proteinuria < 1,000 mg on 24-hour urine collection
• Total bilirubin ≤ 1.5 times ULN
• AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN for patients with liver metastases)
• Albumin ≥ 2.5 g/dL
• Amylase ≤ 2 times ULN
• Lipase ≤ 2 times ULN
• PTT ≤ 1.2 times ULN
• INR ≤ 1.2 times ULN
• No patients with uncontrolled hypophosphatemia, hypocalcemia, hypomagnesemia, hyponatremia, or hypokalemia defined as less than the lower limit of normal for the institution, despite adequateelectrolyte supplementation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use two forms of contraception (i.e., barrier contraception and one other method of contraception) prior to, during, and for ≥ 12 months after study participation
• Patients must not have current evidence of or history of another malignancy except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other curatively treated solid tumors with no evidence of disease for ≥ 3 years prior to enrollment
• Able to swallow capsules
• No malabsorption syndrome or other condition that would interfere with intestinal absorption

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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