ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title:

ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00385021
• Other study ID #: CTCT 06-06
• Status: Terminated
• Phase: Phase 2
• First received: October 4, 2006
• Last updated: October 31, 2007
• Start date: October 2006
• Est. completion date: September 2007

Study information

• Verified date: October 2007
• Source: Southwestern Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To determine efficacy in the delivery of chronomodulated chemotherapy.

Description:

The purpose of this study is to determine if treatment with 5-Fluorouracil, leucovorin, oxaliplatin, and Avastin will cause colorectal tumor cells to shrink or disappear. The study will also determine the safety of these drugs when given together and the quality of life of the patients who are enrolled in the study.

It is thought that these drugs will be better tolerated if they are chronomodulated, i.e., if they are given at certain times of day rather than as a continuous infusion.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 86 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• 5-Fluorouracil, leucovorin, oxaliplatin, avastin

Locations

Country	Name	City	State
United States	Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Southwestern Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Click here for more information about this study: ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer