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

Sanofi

Status and phase

Terminated

Phase 4

Conditions

Colorectal Cancer

Treatments

Drug: oxaliplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00129870

L_9444

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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