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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over NCI NCCTG-874652 MAYO-874652, NCCTG-87-46-52

Objectives

I.  Compare, in a randomized, double-blind Phase III setting, survival and 
time to progression among patients with metastatic or locally nonresectable 
colorectal carcinoma who are ambulatory and without significant symptoms 
randomly assigned to treatment with the somatostatin analogue Sandostatin vs. 
no further treatment until documented progression.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed locally
unresectable or metastatic adenocarcinoma arising in the
large bowel

  Site of primary tumor confirmed by endoscopy, surgery, or
  radiography

  Histologic proof of subsequent metastatic disease required
  if metastases to the regional lymph nodes, adjacent
  peritoneum, and other contiguous structures were completely
  resected with the primary

  Further histologic documentation not required if distant
  metastases (e.g., liver, discontiguous nodes) were
  completely resected with primary tumor and subsequent tumor
  masses develop on scan, x-ray, or physical examination

  Clinically diagnosed pulmonary metastases need not be
  biopsied if there are at least 2 new or progressing lesions
  on serial chest x-rays taken between 1 and 12 months apart

Must not be suitable for other potentially curative therapies
such as:

  Focal irradiation for locally recurrent rectal carcinoma

  Resection of isolated pulmonary or hepatic metastases

Must be asymptomatic or minimally symptomatic from cancer
(e.g., any pain must be easily controlled by non-narcotic
analgesics)

Measurable or nonmeasurable disease allowed

Prior/Concurrent Therapy:

Biologic therapy:
  Prior immunotherapy given as adjuvant to potentially
     curative surgery allowed
  Prior immunotherapy for previous malignancy allowed

Chemotherapy:
  No prior chemotherapy for metastatic or unresectable disease
  Prior chemotherapy given as adjuvant to potentially
     curative surgery allowed
  Prior chemotherapy for previous malignancy allowed

Endocrine therapy:
  Not specified

Radiotherapy:
  Prior radiotherapy given as adjuvant to potentially
     curative surgery allowed
  Prior radiotherapy for previous malignancy allowed

Surgery:
  Prior surgery allowed

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0 or 1

Hematopoietic:
  Not specified

Hepatic:
  Bilirubin normal
  Alkaline phosphatase no more than 2 x ULN

Renal:
  Not specified

Other:
  Intellectually, emotionally, and physically capable of
     self-administration of injectable medication
  No second malignancy within 4 years except:
     Nonmelanomatous skin cancer
     Carcinoma in situ of the cervix
  No pregnant or nursing women (negative pregnancy test
     required)

Expected Enrollment

Initially it was planned to randomize 200 patients to treatment with SSTN vs. 
placebo.  About mid-way through the study, the study plan was changed to 
double-blind methodology.  A preliminary analysis is planned after the entry 
of 80 patients into the double-blind phase of the study.  If it appears that 
blinding has had a major influence on declaration of progression for either 
area, the study will be extended to accrue the full group of 200 patients in a 
double blind fashion.

Outline

Randomized study.
Arm I:  Single-agent Somatostatin Analogue Therapy.  Octreotide, Sandostatin, 
SSTN.
Arm II:  Placebo.

Krook J, Goldberg RM, Moertel CG, et al.: A phase III evaluation of the somatostatin analogue octreotide in the therapy (Rx) of asymptomatic advanced colon cancer (AACC): a North Central Cancer Treatment Group study (NCCTG). [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-556, 191, 1993.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Richard Goldberg, MD, Protocol chair(Contact information may not be current)		Ph: 507-266-0029 Email: goldberg.richard@mayo.edu

Mayo Clinic Cancer Center

Charles G. Moertel, MD, Protocol chair(Contact information may not be current)		Ph: 507-284-2511