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A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate ca...
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| Zeitschriftentitel: | Journal of Clinical Oncology |
|---|---|
| Personen und Körperschaften: | , , , , , , , |
| In: | Journal of Clinical Oncology, 33, 2015, 7_suppl, S. 238-238 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
American Society of Clinical Oncology (ASCO)
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| Schlagwörter: |
| author_facet |
Aggarwal, Rahul Raj Bryce, Alan H. Weinberg, Vivian K. Ryan, Charles J. Derleth, Christina Louise Harzstark, Andrea Lee, Mina Small, Eric Jay Aggarwal, Rahul Raj Bryce, Alan H. Weinberg, Vivian K. Ryan, Charles J. Derleth, Christina Louise Harzstark, Andrea Lee, Mina Small, Eric Jay |
|---|---|
| author |
Aggarwal, Rahul Raj Bryce, Alan H. Weinberg, Vivian K. Ryan, Charles J. Derleth, Christina Louise Harzstark, Andrea Lee, Mina Small, Eric Jay |
| spellingShingle |
Aggarwal, Rahul Raj Bryce, Alan H. Weinberg, Vivian K. Ryan, Charles J. Derleth, Christina Louise Harzstark, Andrea Lee, Mina Small, Eric Jay Journal of Clinical Oncology A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). Cancer Research Oncology |
| author_sort |
aggarwal, rahul raj |
| spelling |
Aggarwal, Rahul Raj Bryce, Alan H. Weinberg, Vivian K. Ryan, Charles J. Derleth, Christina Louise Harzstark, Andrea Lee, Mina Small, Eric Jay 0732-183X 1527-7755 American Society of Clinical Oncology (ASCO) Cancer Research Oncology http://dx.doi.org/10.1200/jco.2015.33.7_suppl.238 <jats:p> 238 </jats:p><jats:p> Background: Cbz/pred extends survival in mCRPC patients (pts) following docetaxel and first-line studies comparing Cbz to docetaxel are ongoing. Mito/pred also has anti-tumor activity in mCRPC and a non-overlapping mechanism of action and toxicity profile with Cbz. A multicenter phase 1 trial was initiated through the DOD PCCTC to establish the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of Cbz, Mito, and Pred (CAMP). Methods: Chemotherapy (chemo)-naïve pts with mCRPC were enrolled in an accelerated titration design. The primary objective was to determine the MTD and RP2D of CAMP; secondary objectives included PSA response rate and duration of response. Cbz 20 and 25 mg/m<jats:sup>2 </jats:sup>were each evaluated in combination with escalating doses of Mito (starting dose 4 mg/m<jats:sup>2</jats:sup>), both administered on day 1 of a 21-day cycle. Pred 5 mg BID and pegfilgrastim were given with each cycle. Results: 20 pts were enrolled. The median age was 66 (range 51-78) and the median baseline PSA was 62.5 (range 3.0-791.2). There were 2 DLTs observed at the dose level of Cbz 25 mg/m<jats:sup>2</jats:sup> + Mito 10 mg/m<jats:sup>2</jats:sup> (sepsis and febrile neutropenia). No DLTs were observed with Cbz 20 mg/m<jats:sup>2 </jats:sup>(N = 10), establishing Cbz 20 mg/m<jats:sup>2</jats:sup> + Mito 12 mg/m<jats:sup>2</jats:sup> as the MTD and RP2D. The most common grade ≥ 3 related adverse events were hematologic (neutropenia, n = 8; thrombocytopenia, n = 3; febrile neutropenia, n = 2). No cardiac adverse events were observed. The median number of treatment cycles was 9 (range 2-16), and 5 pts remain on study. Greater than 50% maximal PSA declines from baseline were observed in 8 of 18 evaluable pts (44%). Objective tumor responses have been observed in 2 of 4 pts (50%) with measurable disease, with evaluation ongoing. The median duration of response has not been reached (range 4.9-10.0+ months). Conclusions: The approved single-agent dose of Mito (12 mg/m<jats:sup>2</jats:sup>) was safely combined with Cbz 20 mg/m<jats:sup>2</jats:sup>, a dose with demonstrated activity in mCRPC and potentially less hematologic toxicity than 25 mg/m<jats:sup>2</jats:sup>. Preliminary efficacy data are encouraging with durable responses observed in a subset of pts. Further study of the treatment combination is warranted. Clinical trial information: NCT01594918. </jats:p> A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). Journal of Clinical Oncology |
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| title |
A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). |
| title_unstemmed |
A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). |
| title_full |
A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). |
| title_fullStr |
A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). |
| title_full_unstemmed |
A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). |
| title_short |
A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). |
| title_sort |
a multicenter phase i study of cabazitaxel (cbz), mitoxantrone (mito), and prednisone (pred) (camp) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mcrpc). |
| topic |
Cancer Research Oncology |
| url |
http://dx.doi.org/10.1200/jco.2015.33.7_suppl.238 |
| publishDate |
2015 |
| physical |
238-238 |
| description |
<jats:p> 238 </jats:p><jats:p> Background: Cbz/pred extends survival in mCRPC patients (pts) following docetaxel and first-line studies comparing Cbz to docetaxel are ongoing. Mito/pred also has anti-tumor activity in mCRPC and a non-overlapping mechanism of action and toxicity profile with Cbz. A multicenter phase 1 trial was initiated through the DOD PCCTC to establish the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of Cbz, Mito, and Pred (CAMP). Methods: Chemotherapy (chemo)-naïve pts with mCRPC were enrolled in an accelerated titration design. The primary objective was to determine the MTD and RP2D of CAMP; secondary objectives included PSA response rate and duration of response. Cbz 20 and 25 mg/m<jats:sup>2 </jats:sup>were each evaluated in combination with escalating doses of Mito (starting dose 4 mg/m<jats:sup>2</jats:sup>), both administered on day 1 of a 21-day cycle. Pred 5 mg BID and pegfilgrastim were given with each cycle. Results: 20 pts were enrolled. The median age was 66 (range 51-78) and the median baseline PSA was 62.5 (range 3.0-791.2). There were 2 DLTs observed at the dose level of Cbz 25 mg/m<jats:sup>2</jats:sup> + Mito 10 mg/m<jats:sup>2</jats:sup> (sepsis and febrile neutropenia). No DLTs were observed with Cbz 20 mg/m<jats:sup>2 </jats:sup>(N = 10), establishing Cbz 20 mg/m<jats:sup>2</jats:sup> + Mito 12 mg/m<jats:sup>2</jats:sup> as the MTD and RP2D. The most common grade ≥ 3 related adverse events were hematologic (neutropenia, n = 8; thrombocytopenia, n = 3; febrile neutropenia, n = 2). No cardiac adverse events were observed. The median number of treatment cycles was 9 (range 2-16), and 5 pts remain on study. Greater than 50% maximal PSA declines from baseline were observed in 8 of 18 evaluable pts (44%). Objective tumor responses have been observed in 2 of 4 pts (50%) with measurable disease, with evaluation ongoing. The median duration of response has not been reached (range 4.9-10.0+ months). Conclusions: The approved single-agent dose of Mito (12 mg/m<jats:sup>2</jats:sup>) was safely combined with Cbz 20 mg/m<jats:sup>2</jats:sup>, a dose with demonstrated activity in mCRPC and potentially less hematologic toxicity than 25 mg/m<jats:sup>2</jats:sup>. Preliminary efficacy data are encouraging with durable responses observed in a subset of pts. Further study of the treatment combination is warranted. Clinical trial information: NCT01594918. </jats:p> |
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| author | Aggarwal, Rahul Raj, Bryce, Alan H., Weinberg, Vivian K., Ryan, Charles J., Derleth, Christina Louise, Harzstark, Andrea, Lee, Mina, Small, Eric Jay |
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| description | <jats:p> 238 </jats:p><jats:p> Background: Cbz/pred extends survival in mCRPC patients (pts) following docetaxel and first-line studies comparing Cbz to docetaxel are ongoing. Mito/pred also has anti-tumor activity in mCRPC and a non-overlapping mechanism of action and toxicity profile with Cbz. A multicenter phase 1 trial was initiated through the DOD PCCTC to establish the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of Cbz, Mito, and Pred (CAMP). Methods: Chemotherapy (chemo)-naïve pts with mCRPC were enrolled in an accelerated titration design. The primary objective was to determine the MTD and RP2D of CAMP; secondary objectives included PSA response rate and duration of response. Cbz 20 and 25 mg/m<jats:sup>2 </jats:sup>were each evaluated in combination with escalating doses of Mito (starting dose 4 mg/m<jats:sup>2</jats:sup>), both administered on day 1 of a 21-day cycle. Pred 5 mg BID and pegfilgrastim were given with each cycle. Results: 20 pts were enrolled. The median age was 66 (range 51-78) and the median baseline PSA was 62.5 (range 3.0-791.2). There were 2 DLTs observed at the dose level of Cbz 25 mg/m<jats:sup>2</jats:sup> + Mito 10 mg/m<jats:sup>2</jats:sup> (sepsis and febrile neutropenia). No DLTs were observed with Cbz 20 mg/m<jats:sup>2 </jats:sup>(N = 10), establishing Cbz 20 mg/m<jats:sup>2</jats:sup> + Mito 12 mg/m<jats:sup>2</jats:sup> as the MTD and RP2D. The most common grade ≥ 3 related adverse events were hematologic (neutropenia, n = 8; thrombocytopenia, n = 3; febrile neutropenia, n = 2). No cardiac adverse events were observed. The median number of treatment cycles was 9 (range 2-16), and 5 pts remain on study. Greater than 50% maximal PSA declines from baseline were observed in 8 of 18 evaluable pts (44%). Objective tumor responses have been observed in 2 of 4 pts (50%) with measurable disease, with evaluation ongoing. The median duration of response has not been reached (range 4.9-10.0+ months). Conclusions: The approved single-agent dose of Mito (12 mg/m<jats:sup>2</jats:sup>) was safely combined with Cbz 20 mg/m<jats:sup>2</jats:sup>, a dose with demonstrated activity in mCRPC and potentially less hematologic toxicity than 25 mg/m<jats:sup>2</jats:sup>. Preliminary efficacy data are encouraging with durable responses observed in a subset of pts. Further study of the treatment combination is warranted. Clinical trial information: NCT01594918. </jats:p> |
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| spelling | Aggarwal, Rahul Raj Bryce, Alan H. Weinberg, Vivian K. Ryan, Charles J. Derleth, Christina Louise Harzstark, Andrea Lee, Mina Small, Eric Jay 0732-183X 1527-7755 American Society of Clinical Oncology (ASCO) Cancer Research Oncology http://dx.doi.org/10.1200/jco.2015.33.7_suppl.238 <jats:p> 238 </jats:p><jats:p> Background: Cbz/pred extends survival in mCRPC patients (pts) following docetaxel and first-line studies comparing Cbz to docetaxel are ongoing. Mito/pred also has anti-tumor activity in mCRPC and a non-overlapping mechanism of action and toxicity profile with Cbz. A multicenter phase 1 trial was initiated through the DOD PCCTC to establish the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of Cbz, Mito, and Pred (CAMP). Methods: Chemotherapy (chemo)-naïve pts with mCRPC were enrolled in an accelerated titration design. The primary objective was to determine the MTD and RP2D of CAMP; secondary objectives included PSA response rate and duration of response. Cbz 20 and 25 mg/m<jats:sup>2 </jats:sup>were each evaluated in combination with escalating doses of Mito (starting dose 4 mg/m<jats:sup>2</jats:sup>), both administered on day 1 of a 21-day cycle. Pred 5 mg BID and pegfilgrastim were given with each cycle. Results: 20 pts were enrolled. The median age was 66 (range 51-78) and the median baseline PSA was 62.5 (range 3.0-791.2). There were 2 DLTs observed at the dose level of Cbz 25 mg/m<jats:sup>2</jats:sup> + Mito 10 mg/m<jats:sup>2</jats:sup> (sepsis and febrile neutropenia). No DLTs were observed with Cbz 20 mg/m<jats:sup>2 </jats:sup>(N = 10), establishing Cbz 20 mg/m<jats:sup>2</jats:sup> + Mito 12 mg/m<jats:sup>2</jats:sup> as the MTD and RP2D. The most common grade ≥ 3 related adverse events were hematologic (neutropenia, n = 8; thrombocytopenia, n = 3; febrile neutropenia, n = 2). No cardiac adverse events were observed. The median number of treatment cycles was 9 (range 2-16), and 5 pts remain on study. Greater than 50% maximal PSA declines from baseline were observed in 8 of 18 evaluable pts (44%). Objective tumor responses have been observed in 2 of 4 pts (50%) with measurable disease, with evaluation ongoing. The median duration of response has not been reached (range 4.9-10.0+ months). Conclusions: The approved single-agent dose of Mito (12 mg/m<jats:sup>2</jats:sup>) was safely combined with Cbz 20 mg/m<jats:sup>2</jats:sup>, a dose with demonstrated activity in mCRPC and potentially less hematologic toxicity than 25 mg/m<jats:sup>2</jats:sup>. Preliminary efficacy data are encouraging with durable responses observed in a subset of pts. Further study of the treatment combination is warranted. Clinical trial information: NCT01594918. </jats:p> A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). Journal of Clinical Oncology |
| spellingShingle | Aggarwal, Rahul Raj, Bryce, Alan H., Weinberg, Vivian K., Ryan, Charles J., Derleth, Christina Louise, Harzstark, Andrea, Lee, Mina, Small, Eric Jay, Journal of Clinical Oncology, A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC)., Cancer Research, Oncology |
| title | A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). |
| title_full | A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). |
| title_fullStr | A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). |
| title_full_unstemmed | A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). |
| title_short | A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). |
| title_sort | a multicenter phase i study of cabazitaxel (cbz), mitoxantrone (mito), and prednisone (pred) (camp) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mcrpc). |
| title_unstemmed | A multicenter phase I study of cabazitaxel (Cbz), mitoxantrone (Mito), and prednisone (Pred) (CAMP) for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). |
| topic | Cancer Research, Oncology |
| url | http://dx.doi.org/10.1200/jco.2015.33.7_suppl.238 |