Journal of Clinical Oncology, Vol 16, 3649-3655, Copyright © 1998 by American Society of Clinical Oncology
Phase I/II trial of the safety and efficacy of shark cartilage in the treatment of advanced cancer
DR Miller, GT Anderson, JJ Stark, JL Granick and D Richardson
Cancer Treatment Research Foundation, Cancer Treatment Centers of America, Arlington Heights, IL 60005, USA. gary.anderson@ctca-corp.com
PURPOSE: Patients with cancer and chronic inflammatory disorders have used
shark cartilage (SC) preparations for many years. Preclinical studies that
support their beneficial effects are scanty, and reports of clinical trials
have been anecdotal. The proposed mechanisms of antitumor action include
direct or indirect inhibition of angiogenesis. Because of the emerging use
of SC as an alternative to conventional cancer therapy, this trial was
launched to evaluate the safety and efficacy of SC. PATIENTS AND METHODS:
Sixty adult patients with advanced previously treated cancer (breast, 16
patients; colorectal, 16 patients; lung, 14 patients; prostate, eight
patients; non-Hodgkin lymphoma, three patients; brain, one patient; and
unknown primary tumor, two patients) were enrolled. Eligibility criteria
included confirmation of diagnosis, resistance to conventional therapy,
objective measurable disease, life expectancy of 12 weeks or greater,
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, no
recent or concomitant anticancer therapy, no prior SC, and informed
consent. Patients underwent evaluation of the extent of disease,
quality-of-life score (Functional Assessment of Cancer Therapy-General
[FACT-G] scale), and hematologic, biochemical, and selected immune function
studies at baseline and after 6 and 12 weeks of SC therapy. The dose of SC
was 1 g/kg daily orally in three divided doses. Standard criteria were used
to evaluate adverse events and response. RESULTS: Ten of 60 patients were
lost to follow-up(LTFU) or refused further treatment (RFT) before the
6-week evaluation and were not assessable for toxicity and response. Three
patients with stable disease at 6 weeks were LTFU or RFT thereafter. Of the
47 fully assessable patients, five were taken off study because of
gastrointestinal toxicity or intolerance to SC. Progressive disease (PD) at
6 or 12 weeks occurred in 22 and five patients, respectively. Five patients
died of PD while undergoing SC therapy. No complete (CRs) or partial
responses (PRs) were noted. Median time to tumor progression in the entire
study population was 7+/-9.7 weeks (mean, 11.4 weeks; range, 3.7 to 45.7
weeks). Ten (20%) of 50 assessable patients, or 16.7% of the 60 intent-
to-treat patients, had stable disease (SD) for 12 weeks or more. The median
time to tumor progression was 27 weeks, the mean was 28.8+/-9.9 weeks, and
the range was 18.6 to 45.7 weeks. In this subset, FACT-G scores improved in
four patients, were unchanged in four patients, and declined in two
patients. Twenty-one adverse events (grade 1, eight events; grade 2, seven
events; and grade 3, six events) were recorded, 14 of which were
gastroenterologic (nausea, vomiting, constipation). CONCLUSION: Under the
specific conditions of this study, SC as a single agent was inactive in
patients with advanced-stage cancer and had no salutary effect on quality
of life. The 16.7% rate of SD was similar to results in patients with
advanced cancer treated with supportive care alone.
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