Phase III Evaluation Of Benefin Shark Cartilage In Patients With Advanced Cancer
18 Years
N/A
Both
Breast Cancer, Colorectal Cancer
Trial Information
Phase III Evaluation Of Benefin Shark Cartilage In Patients With Advanced 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.
- Arm I: Patients receive oral shark cartilage (BeneFin™) 3-4 times daily.
- Arm II: Patients receive oral placebo 3-4 times daily. Treatment continues in the
absence of unacceptable toxicity.
Quality of life is assessed weekly for 1 month and then monthly thereafter during treatment.
Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this
study within 24 months.
Inclusion Criteria
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)
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Male or female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- Not specified
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:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- Concurrent chemotherapy allowed
- No concurrent participation in a cytotoxic chemotherapy clinical trial
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- At least 60 days since prior shark cartilage
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Principal Investigator
Charles L. Loprinzi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000068987
NCT ID:
NCT00026117
Start Date:
August 2001
Completion Date:
Related Keywords:
- Breast Cancer
- Colorectal Cancer
- stage IV colon cancer
- stage IV breast cancer
- recurrent breast cancer
- stage IV rectal cancer
- recurrent colon cancer
- recurrent rectal cancer
- male breast cancer
- Breast Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
| Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
| CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| Mayo Clinic | Jacksonville, Florida 32224 |
| Medcenter One Health System | Bismarck, North Dakota 58501 |
| CentraCare Health Plaza | Saint Cloud, Minnesota 56303 |
