Oxaliplatin in Rectal Cancer

Sanofi

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Rectal Neoplasms

Treatments

Drug: Oxaliplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00259363

L_8330

Details and patient eligibility

About

Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study
Phase II: To determine the treatment efficacy according to response rates from phase I.

Enrollment

46 patients

Sex

All

Ages

18 to 80 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.

Main criteria are listed hereafter:

Inclusion Criteria:

ECOG: 0-2
Histological proved rectal adenocarcinoma
No chemotherapy treatment on the previous 6 months before inclusion.
No previous pelvic radiotherapy treatment

Exclusion Criteria:

Important Biological abnormality (renal, hepatic and/or hematological)
Intestinal occlusion or subocclusion
Peripheral neuropathy
Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test.
Participation in other trials on the previous 4 months.