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Anti-metabolites

Chemotherapy +/− Bevacizumab for Stage II Colon Cancer

Phase 3

Waitlist Available

Led By Al B Benson

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have paraffin-embedded tumor specimen available for evaluation of microsatellite instability and loss of heterozygosity at 18q

Patients must not have synchronous tumors

Must not have

History of any lymphoproliferative disorder

History of active malignancy within 5 years prior to screening (exceptions for basal cell carcinoma and squamous cell carcinoma)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a combination of drugs to treat patients who have had surgery for stage II colon cancer, to see if it is more effective than a standard combination of drugs.

Who is the study for?

This trial is for patients who've had surgery for stage II colon cancer. They should have stable blood pressure, no severe neuropathy, and no history of inflammatory bowel disease or significant bleeding unrelated to their tumor. Participants must not have started any other treatments for this cancer, be in good physical condition (ECOG 0-2), and agree to use contraception if applicable. Those with certain heart conditions or a history of serious blood clots can't join.

What is being tested?

The study compares two treatment methods after surgery: one group receives chemotherapy drugs oxaliplatin, leucovorin calcium, fluorouracil alone; the other gets these drugs plus bevacizumab, an antibody that may block tumor growth. The goal is to find out which combination is more effective against colon cancer.

What are the potential side effects?

Chemotherapy may cause nausea, fatigue, nerve damage (neuropathy), low blood counts leading to increased infection risk or bleeding problems. Bevacizumab might add risks like high blood pressure, bleeding issues, slow wound healing and could affect organs like kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a tumor sample available for specific genetic testing.

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I do not have more than one tumor at the same time.

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I do not have a tumor in my appendix.

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I have not had a stroke or mini-stroke in the last year.

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I do not have symptoms from peripheral vascular disease.

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My tumor is located at least 12 cm from the anal opening, as confirmed by a doctor.

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My colon cancer is confirmed to be Stage II adenocarcinoma.

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I have hereditary non-polyposis colorectal cancer.

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I have never had inflammatory bowel disease.

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I have never had cancer spread to distant parts of my abdomen.

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My surgery removed all visible cancer without leaving any behind.

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I have not had a complete blockage or tear in my intestines.

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I haven't started any treatment for my cancer.

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I do not have another type of cancer besides the one being treated.

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I can take care of myself and am up and about more than half of my waking hours.

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I do not have any health conditions that would prevent me from taking the study drugs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a condition where my lymphocytes multiply unusually.

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I haven't had any cancer except for skin cancer in the last 5 years.

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I have symptoms related to poor blood flow in my limbs.

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My cancer has spread to the mesentery but without clear lymph node involvement.

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I have had radiation therapy to my pelvic area before.

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I have a serious or non-healing wound, skin ulcer, or bone fracture.

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I am currently experiencing significant nerve pain or tingling.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Impact of tumor biologic characteristics and their relationship to overall survival

Incidence of adverse events graded by NCI CTCAE 4.0

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (combination chemotherapy, bevacizumab)Experimental Treatment5 Interventions

Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm C (observation)Active Control1 Intervention

Patients undergo observation.

Group III: Arm A (oxaliplatin, leucovorin calcium, fluorouracil)Active Control4 Interventions

Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Leucovorin Calcium

2011

Completed Phase 3

~12500