Phase I trial of sulindac plus 5-fluorouracil and levamisole

Potential adjuvant therapy for colon carcinoma

Frank A Sinicrope, Richard Pazdur, Bernard Levin

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Epidemiological studies indicate that nonsteroidal antiinflammatory agents may reduce colorectal cancer incidence and mortality. Moreover, sulindac has been shown to attenuate the growth and progression of colonic neoplasms in an experimental model of colon carcinoma and in patients with familial adenomatous polyposis. To determine whether sulindac (300 mg/day) would increase toxicity associated with 5-fluorouracil (5-FU) and levamisole, 15 patients with advanced colorectal cancer were treated. Median treatment duration was 3 (range, 0.6-6.0) months, and median age was 56 years (33% ≥ 60 years). All patients had failed prior 5-FU-based therapy, had measurable disease, and were evaluable for toxicity. Grade III/IV granulocytopenia occurred in four patients; three patients had received prior pelvic irradiation resulting in a predisposition to myelosuppression. Two patients developed grade III anemia, and occult gastrointestinal bleeding was suspected in one. No other grade II or greater gastrointestinal or other nonhematological toxicity occurred. One patient had a partial response, 3 patients had disease stabilization, and 10 patients progressed on study. Our results indicate that sulindac does not significantly increase short-term toxicity associated with 5-FU and levamisole. To determine whether sulindac increases the efficacy of adjuvant chemotherapy, we propose a phase III randomized trial in patients with lymph node-positive colon cancer.

Original languageEnglish (US)
Pages (from-to)37-41
Number of pages5
JournalClinical Cancer Research
Volume2
Issue number1
StatePublished - Jan 1996

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Sulindac
Levamisole
Fluorouracil
Colon
Carcinoma
Therapeutics
Colonic Neoplasms
Colorectal Neoplasms
Agranulocytosis
Adenomatous Polyposis Coli
Non-Steroidal Anti-Inflammatory Agents
Adjuvant Chemotherapy
Anemia
Epidemiologic Studies
Theoretical Models
Lymph Nodes

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase I trial of sulindac plus 5-fluorouracil and levamisole : Potential adjuvant therapy for colon carcinoma. / Sinicrope, Frank A; Pazdur, Richard; Levin, Bernard.

In: Clinical Cancer Research, Vol. 2, No. 1, 01.1996, p. 37-41.

Research output: Contribution to journalArticle

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