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Phase III Evaluation Of Benefin Shark Cartilage In Patients With Advanced Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Colorectal Cancer

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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 - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - Merit Care HospitalFargo, North Dakota  58122
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Mayo ClinicJacksonville, Florida  32224
Medcenter One Health SystemBismarck, North Dakota  58501
CentraCare Health PlazaSaint Cloud, Minnesota  56303