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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Completed 16 and over NCI NCI-88-C-168A NCI-MB-226, NCI-T88-0201N, T88-0201

Objectives

I.  Determine the efficacy and risk of combination chemotherapy with 
doxorubicin/etoposide and amiodarone in colorectal and adrenocortical 
carcinomas and pheochromocytomas.
II.  Determine the usefulness of P-170 antagonists in the treatment of 
malignancies that express mdr-1/P-170.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 16 years of age 
with unresectable, biopsy-proven adenocarcinoma of the colon or rectum, 
adrenocortical carcinoma, or pheochromocytoma.  Patients with colorectal 
cancer who have accessible tumor and who are eligible for inclusion in the 
Medicine Branch Protocol NCI-MB-221 are ineligible.  Patients must have 
measurable disease that can be clearly followed by physical examination, 
serial blood samples, or noninvasive diagnostic tests.  Prior chemotherapy is 
allowed provided the cumulative doxorubicin dose has not exceeded 150 mg/sqm; 
prior radiotherapy is allowed provided at least 6 weeks have intervened, bone 
marrow reserves are adequate, and measurable disease exists outside the 
radiation port.  Life expectancy must be at least 8 weeks and performance 
status must be 30% or better on the Karnofsky scale.  Adequate hematologic, 
renal, hepatic, cardiac, and pulmonary function must be demonstrated by the 
following parameters:  WBC greater than 3,000 and platelets greater than 
100,000, unless myelosuppression is due to bone marrow involvement with 
metastatic disease; creatinine less than 2.5 mg/dl; bilirubin less than 1.5 
mg/dl, unless there are documented hepatic metastases; an LVEF of at least 45% 
(determined by radionuclide angiogram); and a DLCO of 70%.  There may be no 
recent myocardial infarction or congestive heart failure, history of cardiac 
arrhythmias currently requiring therapy with antiarrhythmics other than 
amiodarone, history of sinus node dysfunction causing marked sinus 
bradycardia, or history of second- or third-degree AV block.  Chronic 
phenothiazine therapy excludes.  There may be no coexistent second 
malignancies other than basal or squamous cell carcinoma of the skin.  
Patients who are poor medical or psychiatric risks will not be accepted.

Expected Enrollment

Initially, 29 patients will be accrued within each stratification group.  If 
at least one response is noted within a group, a total of 56 evaluable 
patients will be studied in that group.

Outline

Nonrandomized study.
2-Drug Combination Chemotherapy plus Chemopotentiation.  Doxorubicin, DOX, 
NSC-123127; Etoposide, VP-16, NSC-141540; plus Amiodarone.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Antonio Fojo, MD, PhD, Protocol chair		Ph: 301-402-1357 Email: tfojo@helix.nih.gov