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Radiation Therapy and Ixabepilone in Treating Patients With High-Risk Stage III Prostate Cancer After Surgery

Primary Purpose

Prostate Cancer

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ixabepilone

adjuvant therapy

intensity-modulated radiation therapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage III prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Diagnosis of adenocarcinoma of the prostate
- Must have undergone any common form of prostatectomy (e.g., open, perineal, laparoscopic, or robotic) within the past 2 years
- T3 disease or positive surgical margins
- Node negative (N0) and free of distant metastasis (M0) by a bone scan and CT scan or MRI of the pelvis within the past 90 days
- Considered high-risk disease
Gleason score = 7 and post-operative PSA > 0 and ≤ 2 ng/mL OR Gleason score ≥ 8 and post-operative PSA ≥ 0 and ≤ 2 ng/mL
Pre-prostatectomy PSA available
- Range of pre-prostatectomy PSA values not required

PATIENT CHARACTERISTICS:

Zubrod (ECOG) performance status 0-1
ANC ≥ 2,000/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 8 g/dL
Total bilirubin < 1.5 times upper limit of normal (ULN)
AST and ALT < 2.5 times ULN
Alkaline phosphatase < 2.5 times ULN
Fertile patients must use effective contraception during and for 4 weeks after completion of study therapy
Patients with urinary incontinence waiting for stabilization of urinary function after prostatectomy allowed for up to 6 months
No CTCv4 peripheral neuropathy (motor or sensory) ≥ grade 1
No history of inflammatory colitis including Crohn disease or ulcerative colitis
No significant history of psychiatric illness
No other invasive malignancy within the past 3 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the oral cavity
No severe, active co-morbidity with any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring IV antibiotics
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days
- Immunocompromised patients or AIDS based upon current CDC definition
  - HIV testing not required
No history of hypersensitivity reactions to agents containing Cremophor® EL or its derivatives (e.g., polyoxyethylated castor oil)

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior pelvic radiotherapy or radiotherapy for another malignancy that encompasses ≥ 30% of major bone marrow-containing areas (e.g., pelvis or lumbar spine)
No prior hormonal therapy for prostate cancer
- Prior hormonal agents, e.g., finasteride or dutasteride, for benign prostatic hypertrophy allowed
No other concurrent adjuvant antineoplastic therapy planned while on this protocol, including the following:
- Cryotherapy
- Hormonal therapy
- Other chemotherapy for prostate cancer
  - Prior chemotherapy for a different type of cancer allowed provided it was administered > 3 years ago

Sites / Locations

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ixabepilone

Arm Description

Adjuvant therapy

Outcomes

Primary Outcome Measures

Dose-limiting toxicity (phase I)

Maximum-tolerated dose (phase I)

Freedom from progression for 3 years (phase II)

Secondary Outcome Measures

Time to biochemical, local and distant failure (phase II)

Disease-specific survival (phase II)

Overall survival rate (phase II)

Adverse events as assessed by NCI CTCAE v. 4.0

Full Information

NCT ID

NCT01079793

First Posted

March 2, 2010

Last Updated

August 19, 2020

Sponsor

University of Texas Southwestern Medical Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01079793

Brief Title

Radiation Therapy and Ixabepilone in Treating Patients With High-Risk Stage III Prostate Cancer After Surgery

Official Title

A Phase I/II Study of Adjuvant Prostate Irradiation and Ixabepilone For High Risk Prostate Cancer Post-Prostatectomy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Overlapping study, PI preferred to enroll in alternate trial.

Study Start Date

May 26, 2010 (Actual)

Primary Completion Date

October 17, 2011 (Actual)

Study Completion Date

October 17, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Texas Southwestern Medical Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Ixabepilone may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy with chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase I/II trial is studying the side effects and best dose of ixabepilone when given together with radiation therapy to see how well it works in treating patients with high-risk stage III prostate cancer after surgery.

Detailed Description

OBJECTIVES: Primary To determine the maximum-tolerated dose and dose-limiting toxicity of ixabepilone in combination with concurrent intensity-modulated radiation therapy in patients with high-risk prostate cancer after prostatectomy. (Phase I) To determine the toxicity profile of this regimen in these patients. (Phase I) Secondary To assess freedom from progression in patients treated with this regimen. (Phase II) To assess biochemical failure, local failure, and distant failure in patients treated with this regimen. (Phase II) To assess disease-specific survival and overall survival of patients treated with this regimen. (Phase II) To evaluate acute and late toxicity of this regimen in these patients. OUTLINE: This is a phase I, dose-escalation study of ixabepilone followed by a phase II study. Patients undergo adjuvant intensity-modulated radiation therapy once daily, 5 days a week, for 7-9 weeks. Patients also receive concurrent ixabepilone IV over 1 hour on days 1 and 8. Treatment with ixabepilone repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 3 years, and then annually for 6 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage III prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ixabepilone

Arm Type

Experimental

Arm Description

Adjuvant therapy

Intervention Type

Drug

Intervention Name(s)

ixabepilone

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Intervention Type

Radiation

Intervention Name(s)

intensity-modulated radiation therapy

Primary Outcome Measure Information:

Title

Dose-limiting toxicity (phase I)

Description

Dose-limiting toxicity (phase I)

Time Frame

3 years

Title

Maximum-tolerated dose (phase I)

Description

Maximum-tolerated dose (phase I)

Time Frame

3 years

Title

Freedom from progression for 3 years (phase II)

Description

Freedom from progression for 3 years (phase II)

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Time to biochemical, local and distant failure (phase II)

Description

Time to biochemical, local and distant failure (phase II)

Time Frame

3 years

Title

Disease-specific survival (phase II)

Description

Disease-specific survival (phase II)

Time Frame

3 years

Title

Overall survival rate (phase II)

Description

Overall survival rate (phase II)

Time Frame

3 years

Title

Adverse events as assessed by NCI CTCAE v. 4.0

Description

Adverse events as assessed by NCI CTCAE v. 4.0

Time Frame

3 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Diagnosis of adenocarcinoma of the prostate Must have undergone any common form of prostatectomy (e.g., open, perineal, laparoscopic, or robotic) within the past 2 years T3 disease or positive surgical margins Node negative (N0) and free of distant metastasis (M0) by a bone scan and CT scan or MRI of the pelvis within the past 90 days Considered high-risk disease Gleason score = 7 and post-operative PSA > 0 and ≤ 2 ng/mL OR Gleason score ≥ 8 and post-operative PSA ≥ 0 and ≤ 2 ng/mL Pre-prostatectomy PSA available Range of pre-prostatectomy PSA values not required PATIENT CHARACTERISTICS: Zubrod (ECOG) performance status 0-1 ANC ≥ 2,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8 g/dL Total bilirubin < 1.5 times upper limit of normal (ULN) AST and ALT < 2.5 times ULN Alkaline phosphatase < 2.5 times ULN Fertile patients must use effective contraception during and for 4 weeks after completion of study therapy Patients with urinary incontinence waiting for stabilization of urinary function after prostatectomy allowed for up to 6 months No CTCv4 peripheral neuropathy (motor or sensory) ≥ grade 1 No history of inflammatory colitis including Crohn disease or ulcerative colitis No significant history of psychiatric illness No other invasive malignancy within the past 3 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the oral cavity No severe, active co-morbidity with any of the following: Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months Transmural myocardial infarction within the past 6 months Acute bacterial or fungal infection requiring IV antibiotics Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days Immunocompromised patients or AIDS based upon current CDC definition HIV testing not required No history of hypersensitivity reactions to agents containing Cremophor® EL or its derivatives (e.g., polyoxyethylated castor oil) PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior pelvic radiotherapy or radiotherapy for another malignancy that encompasses ≥ 30% of major bone marrow-containing areas (e.g., pelvis or lumbar spine) No prior hormonal therapy for prostate cancer Prior hormonal agents, e.g., finasteride or dutasteride, for benign prostatic hypertrophy allowed No other concurrent adjuvant antineoplastic therapy planned while on this protocol, including the following: Cryotherapy Hormonal therapy Other chemotherapy for prostate cancer Prior chemotherapy for a different type of cancer allowed provided it was administered > 3 years ago

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David A. Pistenmaa, MD

Organizational Affiliation

Simmons Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

12. IPD Sharing Statement

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Radiation Therapy and Ixabepilone in Treating Patients With High-Risk Stage III Prostate Cancer After Surgery

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