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Phase II trial of amonafide in advanced pancreas cancer. A Southwest Oncology Group study
C G Leichman1, C Tangen, J S Macdonald
1University of Southern California School of Medicine, Los Angeles.
Abstract:
Amonafide is a new synthetic anticancer agent whose mechanism of action is through inhibition of macromolecular synthesis as well as DNA intercalation. The Southwest Oncology Group (SWOG) has investigated this drug in a phase II study of pancreas cancer. Thirty-six patients were registered on this study: of these 29 were eligible for response evaluation, and 20 received the two cycles required for making a response assessment. Patients met the standard phase II criteria of no prior chemotherapy, measurable disease and a SWOG performance status of 2 or less. Toxicity, predominantly hematologic with significant neutropenia and thrombocytopenia, was quite severe. Four treatment related deaths were encountered. No responses were seen in thirty-six patients studied. We conclude that this drug is not active against adenocarcinoma of the pancreas.
Insights
Amonafide, a novel anticancer agent, showed severe toxicity and no efficacy in a Phase II study for pancreas cancer. The drug is not active against pancreatic adenocarcinoma.
Area of Science:
- Oncology
- Pharmacology
Background:
- Amonafide is a synthetic anticancer agent that inhibits macromolecular synthesis and DNA intercalation.
- Pancreatic cancer remains a significant challenge with limited effective treatment options.
Purpose of the Study:
- To evaluate the efficacy and toxicity of Amonafide in a Phase II clinical trial for patients with pancreas cancer.
Main Methods:
- A Southwest Oncology Group (SWOG) Phase II study enrolled 36 patients with measurable pancreas cancer and adequate performance status.
- Patients received Amonafide, with 29 eligible for response evaluation and 20 completing the required treatment cycles.
Main Results:
- The study observed significant hematologic toxicities, including neutropenia and thrombocytopenia.
- Four treatment-related deaths occurred. No objective responses were observed in the 36 patients evaluated.
Conclusions:
- Amonafide demonstrated unacceptable toxicity and lack of efficacy in this Phase II study.
- The drug is not considered active against adenocarcinoma of the pancreas.