Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	MDA-DM-94112 NCI-T94-0158H, T94-0158

Objectives

I.  Assess the antitumor activity of 9-aminocamptothecin (9-AC) given in a 
dose of 35 mcg/sqm/hr by 72-hr infusion every 2 weeks to patients with 
metastatic adenocarcinoma of the colon or rectum.

II.  Evaluate the qualitative and quantitative toxicities of 9-AC in these 
patients.

III.  Quantify topoisomerase I-DNA complexes in peripheral blood lymphocytes 
and tumor samples before and after 9-AC therapy.

Entry Criteria

Disease Characteristics:

Histologically confirmed, Stage IV (Dukes' D) adenocarcinoma of the colon or
rectum

Bidimensionally measurable lesions not previously irradiated

No brain metastases

Prior/Concurrent Therapy:

No prior chemotherapy for metastatic disease
At least 6 months since adjuvant chemotherapy
Fully recovered from any surgery

Patient Characteristics:

Age:
  18 and over

Performance status:
  Zubrod 0-2

Life expectancy:
  Greater than 9 weeks

Hematopoietic:
  AGC at least 1,500
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.5 mg/dl

Renal:
  Creatinine no greater than 1.5 mg/dl

Cardiovascular:
  No MI within 6 months
  No CHF
  No uncontrolled angina
  No uncontrolled hypertension

Other:
  No serious infection
  No life-threatening illness other than tumor
  No psychosis or mental disability that precludes informed consent
  No second malignancy within 3 years except:
     Nonmelanomatous skin cancer
     In situ carcinoma of the cervix
  No pregnant or nursing women
  Effective contraception required of fertile women (encouraged in men)

Blood/body fluid analyses within 14 days prior to registration

Expected Enrollment

A maximum of 30 patients will be entered over 12 months in this multicenter 
study.  The study will close if none of the first 14 patients, accrued over 4 
months, responds.

Outline

Single-Agent Chemotherapy.  9-Aminocamptothecin, 9-AC, NSC-603071.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Richard Pazdur, MD, Protocol chair		Ph: 301-594-2473