A phase II trial of marimastat in advanced pancreatic cancer

Br J Cancer. 2001 Dec 14;85(12):1865-70. doi: 10.1054/bjoc.2001.2168.

Abstract

Pancreatic cancer has a poor response to conventional chemotherapy and radiotherapy. Inhibition of matrix metalloproteinase activity involved in tumour invasion and metastases is a novel biological approach for cancer treatment. This multicentre phase II clinical trial assessed marimastat, an oral matrix metalloproteinase inhibitor, in patients with advanced pancreatic cancer. A total of 113 patients received marimastat for 28 days at 100 mg b.d. (n = 9), 25 mg o.d. (n = 90) or 10 mg b.d. (n = 14). Patients with a response to treatment could continue marimastat beyond 28 days. Of 113 patients, 90 (80%) completed the 28-day study and 83 (73%) continued treatment. The principal side effect was arthralgia in 14 (12%) patients at 28 days and 33 (29%) patients over the whole study. There were 31 patients (27%) who required dose modification. Of 76 patients with evaluable CA19-9 levels, 23 (30%) showed no increase or fall in CA19-9. Of 83 patients with radiologically assessable disease, 41 (49%) had stable disease. The median survival was 245 days for those with a stable or falling CA19-9 level 128 days in those with rising CA19-9. The overall survival was 3.8 months. 5.9 months for stage II, 4.7 months for stage III and 3 months for stage IV disease. Of 90 patients, 46 (51%) had stabilization or reduction in pain, mobility and analgesia scores. Further development and clinical evaluation of matrix metalloproteinase inhibitors for the treatment of pancreatic cancer is warranted.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / enzymology
  • Adenocarcinoma / mortality
  • Administration, Oral
  • Adult
  • Aged
  • Aged, 80 and over
  • Biomarkers, Tumor / blood
  • CA-19-9 Antigen / blood
  • Female
  • Gastrointestinal Diseases / chemically induced
  • Humans
  • Hydroxamic Acids / administration & dosage
  • Hydroxamic Acids / adverse effects
  • Hydroxamic Acids / therapeutic use*
  • Life Tables
  • Male
  • Metalloendopeptidases / antagonists & inhibitors*
  • Middle Aged
  • Musculoskeletal Diseases / chemically induced
  • Neoplasm Proteins / antagonists & inhibitors*
  • Neoplasm Staging
  • Pain / etiology
  • Palliative Care
  • Pancreatic Neoplasms / drug therapy*
  • Pancreatic Neoplasms / enzymology
  • Pancreatic Neoplasms / mortality
  • Pilot Projects
  • Protease Inhibitors / administration & dosage
  • Protease Inhibitors / adverse effects
  • Protease Inhibitors / therapeutic use*
  • Quality of Life
  • Survival Analysis
  • Treatment Outcome

Substances

  • Biomarkers, Tumor
  • CA-19-9 Antigen
  • Hydroxamic Acids
  • Neoplasm Proteins
  • Protease Inhibitors
  • marimastat
  • Metalloendopeptidases