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Phase II-III Chemotherapy with PZD, L-PAM, MTX, ICRF-159, ACT-D, YOSHI 864, or CCNU for Advanced Large Bowel Cancer

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

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

No phase specified

Treatment

Closed

no age specified

NCI

EST-1277

Objectives

I.  Determine whether significant, useful activity against colonic and rectal 
adenocarcinoma can be demonstrated (in terms of toxicity, response rate, 
duration of response, duration of survival and quality of survival) as a 
result of treatment with the following:  piperazinedione (PZD), melphalan 
(L-PAM), methotrexate (MTX), ICRF-159, actinomycin-D (ACT-D), Yoshi-864 or 
CCNU (Addendum 2, May 1979).  Continuation of this master protocol can be 
found in EST-1277R.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with nonresectable confirmed 
metastatic or recurrent adenocarcinoma of the colon or rectum with an ECOG 
performance status less than 4 and an expected survival of at least 60 days.  
Radiotherapy for local control must be completed, chemotherapy stopped at 
least 28 days ago and surgery performed at least 2 weeks previously.  Adequate 
hematological, liver and kidney functions are required.

Expected Enrollment

Protocol closed October 1978.

Outline

Randomized study.  Randomize patients with prior therapy to Arms I, IV or VI 
only.
Single-agent Chemotherapies.
Arm I:  Piperazinedione, PZD, NSC-135758.
Arm II:  Melphalan, L-PAM, NSC-8806.
Arm III:  Methotrexate, MTX, NSC-740.
Arm IV:  ICRF-159, NSC-129943.
Arm V:  Actinomycin-D, ACT-D, NSC-3053.
Arm VI:  Yoshi 864, Yoshi, NSC-102627.
Arm VII:  CCNU, NSC-79037.

Related Publications

Douglass HO Jr, MacIntyre JM, Kaufman J, et al.: Eastern Cooperative Oncology Group phase II studies in advanced measurable colorectal cancer. I. Razoxane, Yoshi-864, piperazinedione, and lomustine. Cancer Treat Rep 69 (5): 543-5, 1985.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Paul Carbone, MD, Protocol chair(Contact information may not be current)
Ph: 608-265-8047; 800-622-8922
Email: carbone@biostat.wisc.edu

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.