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

Alternate Title

Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	MDA-DM-96135 NCI-T96-0009H, T96-0009

Objectives

I.  Assess the antitumor activity of aminocamptothecin (9-AC) administered as 
a 5-day continuous infusion for 3 weeks in patients with metastatic colorectal 
adenocarcinoma.

II.  Describe the qualitative and quantitative toxic effects of 9-AC 
administered on this schedule in these patients.
 

Entry Criteria

Disease Characteristics:

Histologically confirmed stage IV (Dukes' stage D) adenocarcinoma of the colon
or rectum
  No brain metastases

Bidimensionally measurable disease with sentinel lesion outside any prior
radiotherapy field

Prior/Concurrent Therapy:

Biologic therapy:
  No concurrent biologic therapy

Chemotherapy:
  No prior chemotherapy for metastatic disease
  At least 6 months since adjuvant chemotherapy
  No prior camptothecin analogues (including irinotecan, topotecan)
  No concurrent chemotherapy

Endocrine therapy:
  No concurrent hormonal therapy

Radiotherapy:
  Prior radiotherapy allowed
  No concurrent radiotherapy

Surgery:
  Fully recovered from any prior surgery
  No concurrent surgery

Patient Characteristics:

Age:
  18 and over

Performance status:
  Zubrod 0-2

Life expectancy:
  Greater than 12 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 active congestive heart failure
  No uncontrolled angina
  No myocardial infarction within 6 months
  No uncontrolled hypertension

Other:
  No other life-threatening illness or serious infection
  No overt psychosis, mental disability, or incompetence that would preclude
     informed consent
  No second malignancy within 5 years except:
     Nonmelanomatous skin cancer
     In situ cervical cancer
  No pregnant or nursing women
     Negative pregnancy test required of fertile women prior to study entry
  Adequate contraception required of fertile patients

Expected Enrollment

Approximately 30 patients will be entered over 6-9 months if there is at least 
1 response in the first 14 evaluable patients.

Outline

Single-Agent Chemotherapy.  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