A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies

Aronex Pharmaceuticals

Status and phase

Unknown

Phase 2

Conditions

Colorectal Neoplasms

Treatments

Drug: Aroplatin (Liposomal NDDP, L-NDDP)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00043199

C-726-01

Details and patient eligibility

About

To determine the rate of response and duration of reponse following therapy with Aroplatin in subjects with advanced colorectal cancer resistant to standard therapies. Secondary objectives are to determine safety and tolerability of the Aroplatin therapy.

Full description

Primary Objective:

To determine response rate (RR; complete and partial response[CR,PR] and duration after therapy with Aroplatin (Liposomal NDDP, L-NDDP) in subjects with locally recurrent, unresectable or metastatic colorectal cancer refractory to 5-FU/leucovorin or capecitabine, and irinotecan.

Secondary Objective:

To determine safety and tolerability of the Aroplatin therapy.

This is a single-arm, open-label phase II study. Subjects refractory to 5-FU/leucovorin or capecitabine, and irinotecan therapies will be enrolled. Dosing will be every four weeks with individual dose escalations and adjustments for toxicity.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Colorectal cancer, locally recurrent, unresectable or metastatic disease (AJCC);
Measurable disease (RECIST criteria);
Cancer refractory to 5-FU/leucovorin or capecitabine, and irinotecan;
ECOG performance score of 0-2;
Adequate hematopoietic, liver and renal function;
Adequate cardiac function (maximum of class II, NYHA);
Women of child-bearing potential must have a negative urine or serum pregnancy test;
Signed written informed consent;
Subjects must be willing to to be followed during the course of treatment/observation and follow-up.

Exclusion criteria

Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer;
Pregnant or breast feeding subjects, or male or female subjects of child producing potential who will not agree to use adequate contraception during the treatment phase of the study;
Prior therapy with oxaliplatin;
Known brain metastases;
Active, uncontrolled infection or other serious medical illnesses;
Subjects may not be using or have used any investigational therapy during four weeks before start of the protocol treatment.