Know Cancer

or
forgot password

CONCEPT - Phase IV, Randomized, Prospective, Multicenter Comparison of Intermittent Schedule of Oxaliplatin Combined With FOLFOX/Bevacizumab vs Conventional Mode of Administration of FOLFOX/Bevacizumab + Neuroprophylaxis With Calcium/Magnesium for Optimization of First-Line Therapy of Metastatic Colorectal Cancer


Phase 4
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

CONCEPT - Phase IV, Randomized, Prospective, Multicenter Comparison of Intermittent Schedule of Oxaliplatin Combined With FOLFOX/Bevacizumab vs Conventional Mode of Administration of FOLFOX/Bevacizumab + Neuroprophylaxis With Calcium/Magnesium for Optimization of First-Line Therapy of Metastatic Colorectal Cancer


The following information on clinical trials is provided for information purposes only to
allow patients and physicians to have an initial discussion about the trial. This
information is not intended to be complete information about the trial, to contain all
considerations that may be relevant to potential participation in the trial, or to replace
the advice of a personal physician or health professional.

Inclusion Criteria:



- Histologically or cytologically documented metastatic, measurable adenocarcinoma of
the colon, rectum, or appendix with no prior therapies for metastatic disease

- ECOG performance status (PS) of 0 or 1

- Adequate hematologic, renal, and hepatic function as defined by required baseline
laboratory parameters

- No other serious concomitant disease.

Exclusion Criteria:

- Peripheral neuropathy > Grade 1 at baseline

- History of significant cerebrovascular, cardiovascular, or peripheral vascular
disease

- Uncontrolled hypertension (defined as blood pressure > 150/100 mmHg)

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess, within 6 months prior to start of study drug

- Minor surgical procedure, fine needle aspiration, or core biopsy within 7 days prior
to start of study drug

- Serious, non-healing wound, ulcer, or bone fracture

- Active gastroduodenal ulcer

- Evidence of bleeding diathesis or coagulopathy

- Significant history of bleeding within 6 months prior to registration

- Prior history of hypertensive crisis or hypertensive encephalopathy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to treatment failure (TTF) for the conventional oxaliplatin (CO) schedule in comparison with the intermittent oxaliplatin (IO) schedule

Principal Investigator

Yasir Nagarwala, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Institutional Review Board

Study ID:

L_9444

NCT ID:

NCT00129870

Start Date:

February 2005

Completion Date:

December 2007

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

Sanofi-AventisBridgewater, New Jersey  08807