Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer

OBJECTIVES:

- Determine whether the addition of powdered shark cartilage (BeneFin™) to standard
therapy improves overall survival in patients with advanced colorectal or breast
cancer.

- Determine whether this therapy has any impact on toxicity in these patients.

- Determine whether this therapy improves the quality of life in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to disease type (breast vs colorectal female vs colorectal male),
age (49 and under vs 50-69 vs 70 and over), ECOG performance status (0-1 vs 2), baseline
quality of life (UNISCALE rating less than 50% vs 50-75% vs more than 75%), and concurrent
chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

DISEASE CHARACTERISTICS:

- Breast or colorectal primary tumor sites

- Considered incurable

- Breast cancer patients must have disease progression after at least 2 different
chemotherapy regimens (may include chemotherapy given as an adjuvant treatment)

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Male or female

Performance status:

- ECOG 0-2

Life expectancy:

- More than 3 months

Hepatic:

- Bilirubin no greater than 3 times upper limit of normal (ULN)

Renal:

- Calcium less than 1.2 times ULN

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Chemotherapy:

- Concurrent chemotherapy allowed

- No concurrent participation in a cytotoxic chemotherapy clinical trial

Other:

- At least 60 days since prior shark cartilage