Phase II trial of dolastatin-10 in patients with advanced breast cancer

Edith A. Perez; David W. Hillman; Paul A. Fishkin; James E. Krook; Winston W. Tan; Phillip A. Kuriakose; Steven R. Alberts; Shaker R. Dakhil

doi:10.1007/s10637-005-6735-y

Phase II trial of dolastatin-10 in patients with advanced breast cancer

Edith A. Perez, David W. Hillman, Paul A. Fishkin, James E. Krook, Winston W. Tan, Phillip A. Kuriakose, Steven R. Alberts, Shaker R. Dakhil

Research output: Contribution to journal › Article › peer-review

79 Scopus citations

Abstract

Purpose: Phase II multicenter cooperative group study investigated the efficacy and toxicity of the novel anti-microtubule agent dolastatin-10 in patients with advanced breast cancer. Patient and methods: Twenty-one patients with measurable metastatic breast cancer were treated with dolastatin-10 at a dose of 400 mcg/m² by intravenous bolus once every 3 weeks. Patients must have received a total of 1 or 2 prior chemotherapy regimens and have an Eastern Cooperative Oncology Group performance status of 0-2. Patients received this treatment as either a first (n = 11) or second-line (n = 10) chemotherapy for metastatic disease. Eighteen patients (86%) had received a prior anthracycline. The National Cancer Institute provided the dolastatin-10. Results: One out of 21 patients (5%; 95% CI: 0-24%) achieved a partial remission for a duration of 113 days. Four patients maintained stable disease for a median of 87 days. A total of 58 courses of dolastatin-10 were administered. Patients received a median of two cycles of dolastatin-10. Hematologic toxicity was moderate, with 8 patients developing grade 4 neutropenia, and 5 with grade 3 neutropenia; one grade 3 febrile neutropenia was observed. These episodes of grade 3 and 4 neutropenia were experienced on 36% of the treatment cycles. Non-hematologic toxicity was uncommon. Conclusion: While the toxicity profile of dolastatin-10 was acceptable, it had minimal activity in this advanced breast cancer study. We are not pursuing further clinical trials of this agent in the setting of advanced breast cancer.

Original language	English (US)
Pages (from-to)	257-261
Number of pages	5
Journal	Investigational New Drugs
Volume	23
Issue number	3
DOIs	https://doi.org/10.1007/s10637-005-6735-y
State	Published - Jun 2005

Keywords

Anti-tubulin agent
Dolastatin-10
Investigational drug
Metastatic breast cancer

ASJC Scopus subject areas

Oncology
Pharmacology
Pharmacology (medical)

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10.1007/s10637-005-6735-y

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title = "Phase II trial of dolastatin-10 in patients with advanced breast cancer",

abstract = "Purpose: Phase II multicenter cooperative group study investigated the efficacy and toxicity of the novel anti-microtubule agent dolastatin-10 in patients with advanced breast cancer. Patient and methods: Twenty-one patients with measurable metastatic breast cancer were treated with dolastatin-10 at a dose of 400 mcg/m2 by intravenous bolus once every 3 weeks. Patients must have received a total of 1 or 2 prior chemotherapy regimens and have an Eastern Cooperative Oncology Group performance status of 0-2. Patients received this treatment as either a first (n = 11) or second-line (n = 10) chemotherapy for metastatic disease. Eighteen patients (86%) had received a prior anthracycline. The National Cancer Institute provided the dolastatin-10. Results: One out of 21 patients (5%; 95% CI: 0-24%) achieved a partial remission for a duration of 113 days. Four patients maintained stable disease for a median of 87 days. A total of 58 courses of dolastatin-10 were administered. Patients received a median of two cycles of dolastatin-10. Hematologic toxicity was moderate, with 8 patients developing grade 4 neutropenia, and 5 with grade 3 neutropenia; one grade 3 febrile neutropenia was observed. These episodes of grade 3 and 4 neutropenia were experienced on 36% of the treatment cycles. Non-hematologic toxicity was uncommon. Conclusion: While the toxicity profile of dolastatin-10 was acceptable, it had minimal activity in this advanced breast cancer study. We are not pursuing further clinical trials of this agent in the setting of advanced breast cancer.",

keywords = "Anti-tubulin agent, Dolastatin-10, Investigational drug, Metastatic breast cancer",

author = "Perez, {Edith A.} and Hillman, {David W.} and Fishkin, {Paul A.} and Krook, {James E.} and Tan, {Winston W.} and Kuriakose, {Phillip A.} and Alberts, {Steven R.} and Dakhil, {Shaker R.}",

note = "Funding Information: ∗This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-15083, CA-63826, CA-35269, CA-35195, CA-52352, CA-35272, CA-35103 and CA-60276 from the National Cancer Institute Department of Health and Human Services.",

year = "2005",

month = jun,

doi = "10.1007/s10637-005-6735-y",

language = "English (US)",

volume = "23",

pages = "257--261",

journal = "Investigational New Drugs",

issn = "0167-6997",

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T1 - Phase II trial of dolastatin-10 in patients with advanced breast cancer

AU - Perez, Edith A.

AU - Hillman, David W.

AU - Fishkin, Paul A.

AU - Krook, James E.

AU - Tan, Winston W.

AU - Kuriakose, Phillip A.

AU - Alberts, Steven R.

AU - Dakhil, Shaker R.

N1 - Funding Information: ∗This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-15083, CA-63826, CA-35269, CA-35195, CA-52352, CA-35272, CA-35103 and CA-60276 from the National Cancer Institute Department of Health and Human Services.

PY - 2005/6

Y1 - 2005/6

N2 - Purpose: Phase II multicenter cooperative group study investigated the efficacy and toxicity of the novel anti-microtubule agent dolastatin-10 in patients with advanced breast cancer. Patient and methods: Twenty-one patients with measurable metastatic breast cancer were treated with dolastatin-10 at a dose of 400 mcg/m2 by intravenous bolus once every 3 weeks. Patients must have received a total of 1 or 2 prior chemotherapy regimens and have an Eastern Cooperative Oncology Group performance status of 0-2. Patients received this treatment as either a first (n = 11) or second-line (n = 10) chemotherapy for metastatic disease. Eighteen patients (86%) had received a prior anthracycline. The National Cancer Institute provided the dolastatin-10. Results: One out of 21 patients (5%; 95% CI: 0-24%) achieved a partial remission for a duration of 113 days. Four patients maintained stable disease for a median of 87 days. A total of 58 courses of dolastatin-10 were administered. Patients received a median of two cycles of dolastatin-10. Hematologic toxicity was moderate, with 8 patients developing grade 4 neutropenia, and 5 with grade 3 neutropenia; one grade 3 febrile neutropenia was observed. These episodes of grade 3 and 4 neutropenia were experienced on 36% of the treatment cycles. Non-hematologic toxicity was uncommon. Conclusion: While the toxicity profile of dolastatin-10 was acceptable, it had minimal activity in this advanced breast cancer study. We are not pursuing further clinical trials of this agent in the setting of advanced breast cancer.

AB - Purpose: Phase II multicenter cooperative group study investigated the efficacy and toxicity of the novel anti-microtubule agent dolastatin-10 in patients with advanced breast cancer. Patient and methods: Twenty-one patients with measurable metastatic breast cancer were treated with dolastatin-10 at a dose of 400 mcg/m2 by intravenous bolus once every 3 weeks. Patients must have received a total of 1 or 2 prior chemotherapy regimens and have an Eastern Cooperative Oncology Group performance status of 0-2. Patients received this treatment as either a first (n = 11) or second-line (n = 10) chemotherapy for metastatic disease. Eighteen patients (86%) had received a prior anthracycline. The National Cancer Institute provided the dolastatin-10. Results: One out of 21 patients (5%; 95% CI: 0-24%) achieved a partial remission for a duration of 113 days. Four patients maintained stable disease for a median of 87 days. A total of 58 courses of dolastatin-10 were administered. Patients received a median of two cycles of dolastatin-10. Hematologic toxicity was moderate, with 8 patients developing grade 4 neutropenia, and 5 with grade 3 neutropenia; one grade 3 febrile neutropenia was observed. These episodes of grade 3 and 4 neutropenia were experienced on 36% of the treatment cycles. Non-hematologic toxicity was uncommon. Conclusion: While the toxicity profile of dolastatin-10 was acceptable, it had minimal activity in this advanced breast cancer study. We are not pursuing further clinical trials of this agent in the setting of advanced breast cancer.

KW - Anti-tubulin agent

KW - Dolastatin-10

KW - Investigational drug

KW - Metastatic breast cancer

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Phase II trial of dolastatin-10 in patients with advanced breast cancer

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Keywords

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