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Trial record 2 of 168 for:    colon cancer AND Colorectal Neoplasms | ( Map: New Jersey, United States )

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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE August 10, 2005
First Posted Date  ICMJE August 12, 2005
Last Update Posted Date February 13, 2009
Study Start Date  ICMJE February 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2005)
Time to treatment failure (TTF) for the conventional oxaliplatin (CO) schedule in comparison with the intermittent oxaliplatin (IO) schedule
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2005)
  • Primary Endpoint:
  • • Time to treatment failure (TTF) for the conventional oxaliplatin (CO) schedule in comparison with the intermittent oxaliplatin (IO) schedule.
Change History Complete list of historical versions of study NCT00129870 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2005)
  • Secondary Endpoint(s):
  • • The incidence of adverse events, including neurotoxicity, as determined using the NCI Common Toxicity Criteria version 3.0 (CTCAEv3.0).
  • • Quality of Life, including oxaliplatin-specific neurologic symptomsdetermined using the PNQoxali.
  • • The magnitude of changes in vibration thresholds as determined using calibrated fixed weight C64 Rydel-Seiffer Tuning Forks.
  • • 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), as discussed in Background and defined under Statistical Methods.
  • • Overall Survival (OS).
  • • Reasons for treatment discontinuation.
  • • For all secondary endpoints the main comparison will be between the CO and IO schedules. The effect of Ca/Mg on each of the tumor-specific endpoints will also be determined in a secondary analysis, as discussed in the Statistical Methods section
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CONCEPT: Comparison of Oxaliplatin vs Conventional Methods With Calcium/Magnesium in First-Line Metastatic Colorectal Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: oxaliplatin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 22, 2008)
180
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00129870
Other Study ID Numbers  ICMJE L_9444
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yasir Nagarwala, M.D. Sanofi
PRS Account Sanofi
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP