search
Back to results

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

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
oxaliplatin
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanofi-Aventis

Outcomes

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

Full Information

First Posted
August 10, 2005
Last Updated
February 12, 2009
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00129870
Brief Title
CONCEPT: Comparison of Oxaliplatin vs Conventional Methods With Calcium/Magnesium in First-Line Metastatic Colorectal Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Terminated
Why Stopped
Unplanned interim analysis by DSMB indicated possible reduced response rate with the addition of Ca/Mg in pooled population. Further analysis pending.
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Primary Outcome Measure Information:
Title
Time to treatment failure (TTF) for the conventional oxaliplatin (CO) schedule in comparison with the intermittent oxaliplatin (IO) schedule
Secondary Outcome Measure Information:
Title
The incidence of adverse events, including neurotoxicity, as determined using the National Cancer Institute (NCI) Common Toxicity Criteria version 3.0 (CTCAE v3.0)
Title
Quality of life, including oxaliplatin-specific neurologic symptoms determined using the PNQoxali
Title
Tumor response rate (overall and confirmed) based on application of the Response Evaluation Criteria in Solid Tumors (RECIST)
Title
Time to tumor progression (TTP)
Title
Time of tumor control (TTC)
Title
Overall survival (OS)
Title
Reasons for treatment discontinuation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasir Nagarwala, M.D.
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs