Know Cancer

or
forgot password

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


Phase 1
18 Years
75 Years
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Lee S. Rosen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068764

NCT ID:

NCT00021268

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781