CONCEPT: Comparison of Oxaliplatin vs Conventional Methods With Calcium/Magnesium in First-Line Metastatic Colorectal Cancer

This study has been terminated.
(Unplanned interim analysis by DSMB indicated possible reduced response rate with the addition of Ca/Mg in pooled population. Further analysis pending.)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00129870
First received: August 10, 2005
Last updated: February 12, 2009
Last verified: February 2009
  Purpose

The primary rationale for this study is to develop an optimized schedule of administration of FOLFOX + bevacizumab that maximizes the efficacy and safety of this regimen when administered to patients with advanced colorectal cancer. The hypothesis is that the use of an intermittent oxaliplatin (IO) schedule of FOLFOX/bevacizumab will allow these patients to continue on treatment for a longer period of time by reducing the proportion of patients who discontinue therapy early because of treatment-related toxicities and thus increasing the possibility of a longer time to progression.

The primary objective is:

  • To test the hypothesis that an intermittent oxaliplatin (IO) schedule of FOLFOX/bevacizumab will allow patients to remain on therapy for a longer period of time compared to a conventional "treat-to-failure" schedule, by reducing the proportion of patients who discontinue therapy for treatment-related toxicities.

The secondary objectives are:

  • To evaluate the impact of calcium/magnesium infusions on the incidence and severity of neurotoxicity in subjects receiving either the IO or conventional FOLFOX/bevacizumab treatment schedules as first-line treatment for metastatic colorectal cancer.
  • To evaluate the safety and efficacy of the IO versus the conventional schedule + calcium and magnesium infusions, as part of oxaliplatin-based first-line therapy for metastatic colorectal cancer.

Condition Intervention Phase
Colorectal Cancer
Drug: oxaliplatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Time to treatment failure (TTF) for the conventional oxaliplatin (CO) schedule in comparison with the intermittent oxaliplatin (IO) schedule

Secondary Outcome Measures:
  • The incidence of adverse events, including neurotoxicity, as determined using the National Cancer Institute (NCI) Common Toxicity Criteria version 3.0 (CTCAE v3.0)
  • Quality of life, including oxaliplatin-specific neurologic symptoms determined using the PNQoxali
  • Tumor response rate (overall and confirmed) based on application of the Response Evaluation Criteria in Solid Tumors (RECIST)
  • Time to tumor progression (TTP)
  • Time of tumor control (TTC)
  • Overall survival (OS)
  • Reasons for treatment discontinuation

Enrollment: 180
Study Start Date: February 2005
Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129870

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Yasir Nagarwala, M.D. Sanofi
  More Information

No publications provided

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00129870     History of Changes
Other Study ID Numbers: L_9444
Study First Received: August 10, 2005
Last Updated: February 12, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014