Back to resultsFractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer
Primary Purpose
Metastatic Castrate Resistant Prostate Cancer
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Radium 223
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Castrate Resistant Prostate Cancer focused on measuring Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Documented metastatic castration resistant disease with PSA progression, radiographic progression, or both, despite medical or surgical castration
- Two or more bone metastases detected on skeletal scintigraphy
- Eligible for docetaxel chemotherapy
- ECOG Performance Status 0-2
Adequate organ function:
- Hemoglobin > 10 g/dL
- Absolute Neutrophil Count ≥ 1,500 K/mL
- Platelet count ≥ 150,000 x 10^9/L
- Total bilirubin ≤ 1.5x upper limit of normal range, excluding Gilbert syndrome
- Serum AST ≤ 1.5 x upper limit of normal range
- Serum ALT ≤ 1.5 x upper limit of normal range
- Estimated glomerular filtration rate (GFR) > 30mL/min
- Ongoing castration (androgen deprivation therapy or prior orchiectomy)
- Male subjects with female sexual partners of childbearing potential must agree to use at least one highly effective methods of birth control.
- Ability to understand and willingness to sign an informed consent form prior to initiation of any study procedures.
- Age ≥ 18 years
Exclusion Criteria:
- Prior radionuclide therapy for CRPC
- Prior docetaxel for CRPC. (Permitted if given for castration sensitive disease > 6 months prior).
- Antiandrogen therapy within 4 weeks of enrollment. However, patients with primary failure of secondary anti-androgen therapy OR symptomatic progression, objective progression and/or biochemical evidence of rising PSA less than 4 weeks after discontinuation of anti-androgen therapy will not have anti-androgen withdrawal responses and will not be excluded.
- Preexisting peripheral neuropathy grade 2 or higher.
- Other serious medical condition as judged by the investigator.
- Active second malignancy that requires therapy.
- Known brain or leptomeningeal metastases
- Concurrent enrollment in any other investigational anticancer therapy
- Treatment with any myelosuppressive agent within 30 days of enrollment
Presence of bulky visceral metastases, defined as any of the following:
- ≥ 4 lung lesions (at least 1cm each in size in the longest diameter) or pulmonary lymphangitic metastasis
- Liver metastases with sum of lesion diameters totaling ≥ 5cm
- Evidence of neuroendocrine or small cell differentiation on prior biopsy
- History of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80
Sites / Locations
- Lahey Hospital & Medical CenterRecruiting
- Tufts Medical CenterRecruiting
- Henry Ford Health SystemRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose escalation
Dose expansion
Arm Description
There are four dose cohorts (1, 1a, 2, 2a) in this arm and two dose levels of docetaxel (40mg/m^2 [level 1] and 50mg/m^2 [level 2]). Dosing of Radium 223 remains the same in all cohorts (55 KBq/kg given every 28 days for 6 cycles). Maximum tolerated dose (MTD) of docetaxel will be assessed. MTD is defined as the highest dose-level, among those tested, associated with a rate of less than a 33% dose limiting toxicity (DLT).
If the maximum tolerated dose (MTD) of docetaxel is found in arm 1, this dose level will be expanded to include an additional 25 subjects to confirm the safety and explore the preliminary anti-cancer effect. If the MTD is not identified, the study will be stopped and the expansion cohort will not be accrued.
Outcomes
Primary Outcome Measures
Incidence of Dose Limiting Toxicities (DLT)
DLT is defined as a subject in any cohort experiencing any of the following adverse events during cycle 1 of treatment, until cycle 2 day 1 of treatment: Thrombocytopenia (platelets < 75 x 10^9/L on C1D15 or < 100 x 10^9/L on C2D1), Neutropenia (ANC < 1000 K/mL on C1D15 or ANC < 1500 K/mL on C2D1), Grade 3 (by CTCAE v4) fatigue lasting ≥ 7 days, other non-hematologic toxicity ≥ grade 3, lasting ≥ 48 hours at least possibly related to treatment, or any toxicity (non-hematologic or hematologic) at least possibly related to treatment requiring dose reduction or dose interruption.
Secondary Outcome Measures
Efficacy, assessed as non-progression/progression rate according to prostate cancer working group (PCWG2) criteria
Time to progression of disease, calculated as a time-to-event endpoint
Progression Free Survival (PFS)
Progression free survival is defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression (assessed per PCWG2) or death from any cause
Time to Treatment Failure (TTTF)
A measurement from the date of randomization to the first event which meets the criteria for disease progression (assessed per PCWG2 criteria) or death from any cause
Overall Survival
Overall survival is defined as the interval from first dose date of study drug to death from any cause.
Proportion of Randomized Subjects to Complete Combination Therapy on Schedule per Protocol
The number of subjects who were able to receive both lead-in doses of docetaxel and all 6 cycles of combination docetaxel and Ra223 on time (+/- 7 days).
Response to treatment, as assessed by prostate-specific antigen (PSA) Kinetics and Objective Responses
Measurable disease calculated at each time point in which the data is collected. We will use mixed effect models to explore the temporal trajectories for the outcome changes over time in response to the treatment.
Satisfaction, as assessed by Quality of Life Questionnaires
Measured by the Brief Pain Inventory (BPI) and Functional Assessment of Cancer Therapy (FACT-G) Questionnaires
Response to Treatment, as assessed by Bone Bio-marker Outcomes
Measurement of bone-specific alkaline phosphatase and urine N-telopeptides (laboratory testing)
Full Information
NCT ID
NCT03737370
First Posted
October 25, 2018
Last Updated
February 28, 2023
Sponsor
Tufts Medical Center
Collaborators
Bayer, Lahey Clinic, Henry Ford Hospital, Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03737370
Brief Title
Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer
Official Title
A Phase I Trial of Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer (CRPC)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
Bayer, Lahey Clinic, Henry Ford Hospital, Ohio State University Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to determine the maximum safe dose of Ra-223 in combination with fractionated (split doses) docetaxel when given to subjects and to determine the best administering dose. The study will look at side effects that may happen while taking the combination treatment. A total of approximately 18 subjects will take part in the dose escalation part of the study and an additional 25 subjects will participate in the expansion cohort. This study will be conducted across four centers in the United States.
Detailed Description
The primary objective of this study is to assess the safety and toxicity of a fractionated docetaxel schedule in combination with standard Ra-223.
Secondary Objectives include: assessment of progression-free survival, time to treatment failure, overall survival, ability of subjects to complete 6 cycles of the combination therapy, assessment of Prostate Specific Antigen (PSA) kinetics and objective responses (measurable disease), assessment of quality of life and assessment of bone bio-marker outcomes.
The study features a 4-week lead-in period with docetaxel monotherapy to assess for docetaxel intolerance. The lead-in period is then followed by combination therapy with Ra-223 every 4 weeks for 6 cycles in a traditional Phase I dose-escalation design.
A provision has been made to include prophylactic granulocyte colony stimulating factor (G-CSF) cohorts after the lead-in period if neutropenia is the dose limiting toxicity at either dose level.
The investigators hypothesize that the fractionated dosing of docetaxel will significantly mitigate the hematologic toxicity, preserve antineoplastic activity and allow for maintenance of the 4-weekly Ra-223 schedule.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castrate Resistant Prostate Cancer
Keywords
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose escalation
Arm Type
Experimental
Arm Description
There are four dose cohorts (1, 1a, 2, 2a) in this arm and two dose levels of docetaxel (40mg/m^2 [level 1] and 50mg/m^2 [level 2]). Dosing of Radium 223 remains the same in all cohorts (55 KBq/kg given every 28 days for 6 cycles).
Maximum tolerated dose (MTD) of docetaxel will be assessed. MTD is defined as the highest dose-level, among those tested, associated with a rate of less than a 33% dose limiting toxicity (DLT).
Arm Title
Dose expansion
Arm Type
Experimental
Arm Description
If the maximum tolerated dose (MTD) of docetaxel is found in arm 1, this dose level will be expanded to include an additional 25 subjects to confirm the safety and explore the preliminary anti-cancer effect. If the MTD is not identified, the study will be stopped and the expansion cohort will not be accrued.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Fractionated Docetaxel
Intervention Description
Docetaxel will be administered every 2 weeks (on Day 1 and Day 15 of a 28 day cycle). Fractionated dosing dependent on cohort.
Intervention Type
Radiation
Intervention Name(s)
Radium 223
Other Intervention Name(s)
Ra-223
Intervention Description
Radium 223 will be delivered every 28 days (on day 1) for 6 cycles.
Primary Outcome Measure Information:
Title
Incidence of Dose Limiting Toxicities (DLT)
Description
DLT is defined as a subject in any cohort experiencing any of the following adverse events during cycle 1 of treatment, until cycle 2 day 1 of treatment: Thrombocytopenia (platelets < 75 x 10^9/L on C1D15 or < 100 x 10^9/L on C2D1), Neutropenia (ANC < 1000 K/mL on C1D15 or ANC < 1500 K/mL on C2D1), Grade 3 (by CTCAE v4) fatigue lasting ≥ 7 days, other non-hematologic toxicity ≥ grade 3, lasting ≥ 48 hours at least possibly related to treatment, or any toxicity (non-hematologic or hematologic) at least possibly related to treatment requiring dose reduction or dose interruption.
Time Frame
Up to 29 Days
Secondary Outcome Measure Information:
Title
Efficacy, assessed as non-progression/progression rate according to prostate cancer working group (PCWG2) criteria
Description
Time to progression of disease, calculated as a time-to-event endpoint
Time Frame
From date of randomization until the date of first documented progression or death from any cause, whichever came first, assessed up to 25 years
Title
Progression Free Survival (PFS)
Description
Progression free survival is defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression (assessed per PCWG2) or death from any cause
Time Frame
Up to 25 years
Title
Time to Treatment Failure (TTTF)
Description
A measurement from the date of randomization to the first event which meets the criteria for disease progression (assessed per PCWG2 criteria) or death from any cause
Time Frame
Up to 25 years
Title
Overall Survival
Description
Overall survival is defined as the interval from first dose date of study drug to death from any cause.
Time Frame
Up to 25 years
Title
Proportion of Randomized Subjects to Complete Combination Therapy on Schedule per Protocol
Description
The number of subjects who were able to receive both lead-in doses of docetaxel and all 6 cycles of combination docetaxel and Ra223 on time (+/- 7 days).
Time Frame
Up to 28 weeks
Title
Response to treatment, as assessed by prostate-specific antigen (PSA) Kinetics and Objective Responses
Description
Measurable disease calculated at each time point in which the data is collected. We will use mixed effect models to explore the temporal trajectories for the outcome changes over time in response to the treatment.
Time Frame
From date of randomization until the date of first documented progression or death from any cause, whichever came first, assessed up to 25 years
Title
Satisfaction, as assessed by Quality of Life Questionnaires
Description
Measured by the Brief Pain Inventory (BPI) and Functional Assessment of Cancer Therapy (FACT-G) Questionnaires
Time Frame
From date of randomization until the date of first documented progression or death from any cause, whichever came first, assessed up to 25 years
Title
Response to Treatment, as assessed by Bone Bio-marker Outcomes
Description
Measurement of bone-specific alkaline phosphatase and urine N-telopeptides (laboratory testing)
Time Frame
Up to 28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Documented metastatic castration resistant disease with PSA progression, radiographic progression, or both, despite medical or surgical castration
Two or more bone metastases detected on skeletal scintigraphy
Eligible for docetaxel chemotherapy
ECOG Performance Status 0-2
Adequate organ function:
Hemoglobin > 10 g/dL
Absolute Neutrophil Count ≥ 1,500 K/mL
Platelet count ≥ 150,000 x 10^9/L
Total bilirubin ≤ 1.5x upper limit of normal range, excluding Gilbert syndrome
Serum AST ≤ 1.5 x upper limit of normal range
Serum ALT ≤ 1.5 x upper limit of normal range
Estimated glomerular filtration rate (GFR) > 30mL/min
Ongoing castration (androgen deprivation therapy or prior orchiectomy)
Male subjects with female sexual partners of childbearing potential must agree to use at least one highly effective methods of birth control.
Ability to understand and willingness to sign an informed consent form prior to initiation of any study procedures.
Age ≥ 18 years
Exclusion Criteria:
Prior radionuclide therapy for CRPC
Prior docetaxel for CRPC. (Permitted if given for castration sensitive disease > 6 months prior).
Antiandrogen therapy within 4 weeks of enrollment. However, patients with primary failure of secondary anti-androgen therapy OR symptomatic progression, objective progression and/or biochemical evidence of rising PSA less than 4 weeks after discontinuation of anti-androgen therapy will not have anti-androgen withdrawal responses and will not be excluded.
Preexisting peripheral neuropathy grade 2 or higher.
Other serious medical condition as judged by the investigator.
Active second malignancy that requires therapy.
Known brain or leptomeningeal metastases
Concurrent enrollment in any other investigational anticancer therapy
Treatment with any myelosuppressive agent within 30 days of enrollment
Presence of bulky visceral metastases, defined as any of the following:
≥ 4 lung lesions (at least 1cm each in size in the longest diameter) or pulmonary lymphangitic metastasis
Liver metastases with sum of lesion diameters totaling ≥ 5cm
Evidence of neuroendocrine or small cell differentiation on prior biopsy
History of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Latoya Lashley, MPH
Phone
617-636-5409
Email
llashley@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Lawlor
Phone
617-636-8897
Email
clawlor3@tuftsmedicalcenter.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Mathew, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Hospital & Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Pietras
Phone
781-744-2766
Email
amanda.pietras@lahey.org
First Name & Middle Initial & Last Name & Degree
Brendan J Connell, MD
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Latoya Lashley
Phone
617-636-5409
Email
llashley@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Christian Lawlor
Phone
617-636-8897
Email
clawlor3@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Paul Mathew, MD
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Adams, RN
First Name & Middle Initial & Last Name & Degree
Clara Hwang, MD
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Holmes
First Name & Middle Initial & Last Name & Degree
Edmund Folefac, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer
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