ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

NCT00385021 | Terminated Phase 2

• 1 other identifier: CTCT 06-06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To determine efficacy in the delivery of chronomodulated chemotherapy.

Conditions

Colorectal Neoplasms

Keywords

Advanced; metastatic; colorectal; cancer; Avastin

Outcome Measures

Primary Outcomes (1)

• The primary objective is to determine if the rate of adverse events among patients receiving chronoFOLFOX plus Avastin is acceptable compared to that in previous studies using the FOLFOX4 regimen.

  2 years

Interventions

5-Fluorouracil, leucovorin, oxaliplatin, avastin DRUG

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological proof of adenocarcinoma in primary colon or rectum tumor.
• Evidence of metastatic colorectal cancer or loco-regional recurrence or unresectable disease.
• Ages 18 to 86 years.
• Presence of at least one bi-dimensionally measurable disease with at least one diameter \> or = 2 cm.
• WHO/ECOG performance status \< 3 (0, 1, or 2)
• Prior treatment with oxaliplatin, 5-FU, or leucovorin permitted.
• Signed informed consent

You may not qualify if:

• Peripheral sensory neuropathy \> or = grade 3.
• Serum bilirubin (total) \> 3 X ULN.
• Symptomatic or uncontrolled brain metastasis.
• Metastases limited to bone, pleural effusion, or ascites.
• Uncontrolled overt cardiac disease.
• Uncontrolled hypercalcemia.
• Uncontrolled infections.
• Uncontrolled hypertension (\>180/110)
• History of GI perforation.
• History of arterial thromboembolic events.
• History of congestive heart failure.
• Patients taking warfarin (Coumadin).
• Patients who are pregnant.

Sponsors & Collaborators

• Southwestern Regional Medical Center: lead

Study Sites (1)

Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.

Tulsa, Oklahoma, 74133, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Neoplasms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Petra Ketterl, MD

  Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 4, 2006
• First Posted: October 6, 2006
• Study Start: October 1, 2006
• Study Completion: September 1, 2007
• Last Updated: November 2, 2007

Record last verified: 2007-10

Locations

US (1)