A phase 1/1b study of satraplatin (JM-216) in combination with docetaxel in patients with advanced solid tumors and metastatic castrate-resistant prostate cancer

Jeremy Cetnar, George Wilding, Douglas McNeel, Noelle K. LoConte, Thomas A. McFarland, Jens Eickhoff, Glenn Liu

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Background: Satraplatin is an oral platinum with potential advantages over other platinum agents. This study investigated the combination of satraplatin and docetaxel in a phase 1 study of patients with advanced solid tumor malignancies followed by a phase 1b study in men with chemotherapy naïve metastatic castrate-resistant prostate cancer (CRPC). Methods:In this single institution phase 1/1b study, patients received docetaxel on day 1 and satraplatin on days 1-5 of a 21-day cycle ± granulocyte colony stimulating factor (GCSF). For phase 1b, prednisone 10 mg daily was added. Results:Twenty-nine patients received treatment. Based on 3 dose limiting toxicities (DLT) (grade 4 neutropenia) in 13 patients at dose levels 1 and -1 (docetaxel 60 mg/m2 plus satraplatin 40 mg/m2 and docetaxel 60 mg/m2 plus satraplatin 50 mg/m2) GCSF was administered with subsequent cohorts. A dose level of docetaxel 60 mg/m2 plus satraplatin 50 mg/m2 with GCSF was the starting dose level for phase 1b. At the highest dose in the phase 1b (docetaxel 75 mg/m2 plus satraplatin 50 mg/m2) there were no DLTs. Conclusion:The combination of satraplatin and docetaxel is feasible in solid tumor malignancies. In advanced malignancies, the recommended phase 2 dose is docetaxel 60 mg/m2 IV day 1 with satraplatin 40 mg/m2/d PO days 1-5, without G-CSF, and Docetaxel 70 mg/m2 IV day 1 with Satraplatin 50 mg/m2/day PO days 1-5, with G-CSF support, repeated in 3-week cycles. For patients with CRPC the recommended phase 2 dose is docetaxel 75 mg/m2 IV day 1 with satraplatin 50 mg/m2/d PO days 1-5, with G-CSF and prednisone 10 mg daily, repeated in 3-week cycles.

Original languageEnglish (US)
Pages (from-to)436-441
Number of pages6
JournalUrologic Oncology: Seminars and Original Investigations
Volume31
Issue number4
DOIs
StatePublished - May 2013
Externally publishedYes

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docetaxel
Prostatic Neoplasms
Granulocyte Colony-Stimulating Factor
Neoplasms
Prednisone
Platinum
satraplatin

ASJC Scopus subject areas

  • Oncology
  • Urology

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A phase 1/1b study of satraplatin (JM-216) in combination with docetaxel in patients with advanced solid tumors and metastatic castrate-resistant prostate cancer. / Cetnar, Jeremy; Wilding, George; McNeel, Douglas; LoConte, Noelle K.; McFarland, Thomas A.; Eickhoff, Jens; Liu, Glenn.

In: Urologic Oncology: Seminars and Original Investigations, Vol. 31, No. 4, 05.2013, p. 436-441.

Research output: Contribution to journalArticle

Cetnar, Jeremy ; Wilding, George ; McNeel, Douglas ; LoConte, Noelle K. ; McFarland, Thomas A. ; Eickhoff, Jens ; Liu, Glenn. / A phase 1/1b study of satraplatin (JM-216) in combination with docetaxel in patients with advanced solid tumors and metastatic castrate-resistant prostate cancer. In: Urologic Oncology: Seminars and Original Investigations. 2013 ; Vol. 31, No. 4. pp. 436-441.
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abstract = "Background: Satraplatin is an oral platinum with potential advantages over other platinum agents. This study investigated the combination of satraplatin and docetaxel in a phase 1 study of patients with advanced solid tumor malignancies followed by a phase 1b study in men with chemotherapy na{\"i}ve metastatic castrate-resistant prostate cancer (CRPC). Methods:In this single institution phase 1/1b study, patients received docetaxel on day 1 and satraplatin on days 1-5 of a 21-day cycle ± granulocyte colony stimulating factor (GCSF). For phase 1b, prednisone 10 mg daily was added. Results:Twenty-nine patients received treatment. Based on 3 dose limiting toxicities (DLT) (grade 4 neutropenia) in 13 patients at dose levels 1 and -1 (docetaxel 60 mg/m2 plus satraplatin 40 mg/m2 and docetaxel 60 mg/m2 plus satraplatin 50 mg/m2) GCSF was administered with subsequent cohorts. A dose level of docetaxel 60 mg/m2 plus satraplatin 50 mg/m2 with GCSF was the starting dose level for phase 1b. At the highest dose in the phase 1b (docetaxel 75 mg/m2 plus satraplatin 50 mg/m2) there were no DLTs. Conclusion:The combination of satraplatin and docetaxel is feasible in solid tumor malignancies. In advanced malignancies, the recommended phase 2 dose is docetaxel 60 mg/m2 IV day 1 with satraplatin 40 mg/m2/d PO days 1-5, without G-CSF, and Docetaxel 70 mg/m2 IV day 1 with Satraplatin 50 mg/m2/day PO days 1-5, with G-CSF support, repeated in 3-week cycles. For patients with CRPC the recommended phase 2 dose is docetaxel 75 mg/m2 IV day 1 with satraplatin 50 mg/m2/d PO days 1-5, with G-CSF and prednisone 10 mg daily, repeated in 3-week cycles.",
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AU - McNeel, Douglas

AU - LoConte, Noelle K.

AU - McFarland, Thomas A.

AU - Eickhoff, Jens

AU - Liu, Glenn

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AB - Background: Satraplatin is an oral platinum with potential advantages over other platinum agents. This study investigated the combination of satraplatin and docetaxel in a phase 1 study of patients with advanced solid tumor malignancies followed by a phase 1b study in men with chemotherapy naïve metastatic castrate-resistant prostate cancer (CRPC). Methods:In this single institution phase 1/1b study, patients received docetaxel on day 1 and satraplatin on days 1-5 of a 21-day cycle ± granulocyte colony stimulating factor (GCSF). For phase 1b, prednisone 10 mg daily was added. Results:Twenty-nine patients received treatment. Based on 3 dose limiting toxicities (DLT) (grade 4 neutropenia) in 13 patients at dose levels 1 and -1 (docetaxel 60 mg/m2 plus satraplatin 40 mg/m2 and docetaxel 60 mg/m2 plus satraplatin 50 mg/m2) GCSF was administered with subsequent cohorts. A dose level of docetaxel 60 mg/m2 plus satraplatin 50 mg/m2 with GCSF was the starting dose level for phase 1b. At the highest dose in the phase 1b (docetaxel 75 mg/m2 plus satraplatin 50 mg/m2) there were no DLTs. Conclusion:The combination of satraplatin and docetaxel is feasible in solid tumor malignancies. In advanced malignancies, the recommended phase 2 dose is docetaxel 60 mg/m2 IV day 1 with satraplatin 40 mg/m2/d PO days 1-5, without G-CSF, and Docetaxel 70 mg/m2 IV day 1 with Satraplatin 50 mg/m2/day PO days 1-5, with G-CSF support, repeated in 3-week cycles. For patients with CRPC the recommended phase 2 dose is docetaxel 75 mg/m2 IV day 1 with satraplatin 50 mg/m2/d PO days 1-5, with G-CSF and prednisone 10 mg daily, repeated in 3-week cycles.

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