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ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer


Phase 2
18 Years
86 Years
Not Enrolling
Both
Colorectal Neoplasms

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Trial Information

ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

2 years

Principal Investigator

Petra Ketterl, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Institutional Review Board

Study ID:

CTCT 06-06

NCT ID:

NCT00385021

Start Date:

October 2006

Completion Date:

September 2007

Related Keywords:

  • Colorectal Neoplasms
  • Advanced
  • metastatic
  • colorectal
  • cancer
  • Avastin
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.Tulsa, Oklahoma  74133