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	no age specified	NCI	NCCTG-944654 NCCTG-94-46-54

Objectives

I.  Estimate the objective tumor response rate of patients with previously 
untreated, measurable metastatic colorectal carcinoma treated with 
aminocamptothecin (9-AC) utilizing two different dose schedules.

II.  Evaluate the qualitative and quantitative toxic effects of 9-AC given on 
these two schedules.

III.  Assess the topoisomerase I expression in pretreatment samples by 
immunohistochemical staining.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed recurrent or metastatic colorectal
cancer for which surgery is not considered curative
  Histologic confirmation not required provided:
     Colorectal carcinoma was histologically confirmed previously, pulmonary
     metastases are clinically diagnosed, and no other lesion is accessible
     for biopsy
                               AND
     2 or more nodular new or progressive lesions on chest x-ray
     compared to x-rays taken 1-18 months earlier
         Progression defined as an increase of 25% in the product of
         perpendicular diameters of any 1 lesion and/or appearance of new
         lesions

Bidimensional clearly measurable disease required, i.e.:
  At least 1.0 cm on physical exam or chest x-ray
  At least 3.0 cm on CT or MRI
  At least 5.0 cm on radioisotope liver scan
  Hepatomegaly, palpable at least 5 cm below costal margin with tumor
     involvement documented by biopsy or imaging study (CT or MRI)

No CNS metastases

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior systemic chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy for malignant disease

Surgery:
  At least 21 days since abdominal exploration, with or without intestinal
  resection

Patient Characteristics:

Age:
  Not specified

Performance status:
  ECOG 0-2

Hematopoietic:
  WBC at least 3,500
  Platelets at least 130,000

Hepatic:
  Bilirubin less than 0.5 mg/dL above normal
  AST no greater than 3 times normal

Renal:
  Creatinine less than 0.4 mg/dL above normal

Cardiovascular:
  No myocardial infarction within 6 months
  No current clinical evidence of congestive heart failure

Other:
  No active uncontrolled infection
  No psychiatric disorder that would preclude informed consent or follow-up
  No other severe underlying disease that would preclude treatment
  No second malignancy within 5 years except:
     Adequately treated nonmelanomatous skin cancer
     Other adequately treated noninvasive cancer
  No pregnant or nursing women
  Effective contraception required of fertile patients

Expected Enrollment

For both treatment schedules, if at least 1 response is seen in the first 15 
patients, an additional 15 patients will be entered; if at least 3 responses 
are seen in these 30 patients, 15 additional patients will be entered.  
Accrual will be open to only one schedule at any given time and is expected to 
require 4-12 months.

Outline

Single-Agent Chemotherapy.  Aminocamptothecin, 9-AC, NSC-603071.  Two 
schedules are assessed:  72-hour infusion q 2 weeks (Schedule A) and 120-hour 
infusion q 4 weeks (Schedule B; closed to patient entry as of 12/96).

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Henry Pitot, MD, Protocol chair		Ph: 507-284-2511 Email: pitot.henry@mayo.edu