Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer

NCT00026117 | Completed Phase 3 DMC

• 3 other identifiers: NCCTG-971151CDR0000068987NCCAM
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 16

Brief Summary

RATIONALE: Shark cartilage extract may help shrink or slow the growth of colorectal cancer or breast cancer cells. PURPOSE: Randomized phase III trial to determine the effectiveness of shark cartilage in treating patients who have advanced colorectal cancer or advanced breast cancer.

Conditions

Breast Cancer; Colorectal Cancer

Keywords

stage IV colon cancer; stage IV breast cancer; recurrent breast cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; male breast cancer

Outcome Measures

Primary Outcomes (1)

• overall survival

  Up to 5 years

Secondary Outcomes (1)

• quality of life

  Up to 5 years

Study Arms (2)

BeneFin

EXPERIMENTAL

Patients receive oral shark cartilage (BeneFin™) 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.

Drug: BenFin

placebo

OTHER

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.

Other: placebo

Interventions

BenFin DRUG

BeneFin

placebo OTHER

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (16)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

CentraCare Health Plaza

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Related Publications (1)

• Loprinzi CL, Levitt R, Barton DL, Sloan JA, Atherton PJ, Smith DJ, Dakhil SR, Moore DF Jr, Krook JE, Rowland KM Jr, Mazurczak MA, Berg AR, Kim GP; North Central Cancer Treatment Group. Evaluation of shark cartilage in patients with advanced cancer: a North Central Cancer Treatment Group trial. Cancer. 2005 Jul 1;104(1):176-82. doi: 10.1002/cncr.21107.

  PMID: 15912493 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Breast Neoplasms, Male

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Charles L. Loprinzi, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2001
• First Posted: January 27, 2003
• Study Start: August 1, 2001
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (16)