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A Phase II Study of Aroplatin in Subjects With Recurrent, Unresectable and Metastatic Colorectal Cancer Refractory to 5-Fluorouracil (5-FU)/Leucovorin or Capecitabine, and Irinotecan


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Neoplasms

Thank you

Trial Information

A Phase II Study of Aroplatin in Subjects With Recurrent, Unresectable and Metastatic Colorectal Cancer Refractory to 5-Fluorouracil (5-FU)/Leucovorin or Capecitabine, and Irinotecan


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

C-726-01

NCT ID:

NCT00043199

Start Date:

Completion Date:

Related Keywords:

  • Colorectal Neoplasms
  • Colorectal Neoplasms
  • Colorectal Cancer
  • Colorectal Carcinoma
  • Colorectal Tumor
  • Neoplasms, Colorectal
  • Unresectable
  • Metastatic
  • Refractory
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University Medical CenterTucson, Arizona  85724