Tocladesine in Treating Patients With Recurrent or Progressive Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase I Study Of Tocladesine In Patients With Colorectal Carcinoma Following Therapy With 5-FU And Irinotecan

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00021268
• Other study ID #: ICN-2000-1
• Secondary ID: UCLA-0006008CDR0
• Status: Active, not recruiting
• Phase: Phase 1
• First received: July 11, 2001
• Last updated: August 1, 2013
• Start date: April 2001

Study information

• Verified date: October 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of tocladesine in treating patients who have recurrent or progressive metastatic colorectal cancer.

Description:

OBJECTIVES:

• Determine the maximum tolerated dose of tocladesine in patients with recurrent or progressive metastatic colorectal cancer.

• Determine the qualitative and quantitative toxicity of this drug in these patients.

• Assess any therapeutic activity in patients treated with this drug.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive tocladesine IV continuously on days 1-5 and 8-12. Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of tocladesine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 14 additional patients are treated at this dose level.

PROJECTED ACCRUAL: A total of 3-38 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic carcinoma of the colon or rectum

• Recurrent or progressive after failing prior fluorouracil and irinotecan chemotherapy, sequentially or in combination, unless unable to tolerate irinotecan

• Measurable disease

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST and ALT no greater than 5 times ULN

• PT/aPTT no greater than 1.2 times ULN

Renal:

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance at least 50 mL/min

• No impaired renal function

Cardiovascular:

• No impaired cardiac function

Other:

• No active infection

• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• Not specified

Other:

• No other concurrent anticancer drugs

• No concurrent chronic non-steroidal anti-inflammatory agents

• No concurrent chronic therapeutic anticoagulation

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• tocladesine

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,