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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129870
Recruitment Status : Terminated (Unplanned interim analysis by DSMB indicated possible reduced response rate with the addition of Ca/Mg in pooled population. Further analysis pending.)
First Posted : August 12, 2005
Last Update Posted : February 13, 2009
Information provided by:

Brief Summary:

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 or disease Intervention/treatment Phase
Colorectal Cancer Drug: oxaliplatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : February 2005
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
Drug Information available for: Oxaliplatin

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00129870

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United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
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Study Director: Yasir Nagarwala, M.D. Sanofi

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Responsible Party: Study Director, sanofi-aventis Identifier: NCT00129870    
Other Study ID Numbers: L_9444
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: February 13, 2009
Last Verified: February 2009
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antineoplastic Agents