Prostate CancerPhase 1/2NCT01079793
Radiation Therapy and Ixabepilone in Treating Patients With High-Risk Stage III Prostate Cancer After Surgery
A Phase 1/2 study testing ixabepilone, adjuvant therapy and intensity-modulated radiation therapy in people with Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ixabepilone, adjuvant therapy and intensity-modulated radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2010to 17 Oct 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
About this study
Official title: A Phase I/II Study of Adjuvant Prostate Irradiation and Ixabepilone For High Risk Prostate Cancer Post-Prostatectomy
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- ixabepilone, adjuvant therapy, intensity-modulated radiation therapy
- Keywords
- adenocarcinoma of the prostate, stage III prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ixabepiloneDrug
adjuvant therapyProcedure or surgery
intensity-modulated radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| ixabepilone | Experimental | Adjuvant therapy Receives: Drug: ixabepilone; Procedure: adjuvant therapy; Radiation: intensity-modulated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (phase I)
Dose-limiting toxicity (phase I)
Measured: 3 years
Maximum-tolerated dose (phase I)
Maximum-tolerated dose (phase I)
Measured: 3 years
Freedom from progression for 3 years (phase II)
Freedom from progression for 3 years (phase II)
Measured: 3 years
Secondary outcomes (4)
Time to biochemical, local and distant failure (phase II)
Time to biochemical, local and distant failure (phase II)
Measured: 3 years
Disease-specific survival (phase II)
Disease-specific survival (phase II)
Measured: 3 years
Overall survival rate (phase II)
Overall survival rate (phase II)
Measured: 3 years
Adverse events as assessed by NCI CTCAE v. 4.0
Adverse events as assessed by NCI CTCAE v. 4.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study start26 May 2010
- Primary completion17 Oct 2011
- Study completion17 Oct 2011
Why it stopped: Overlapping study, PI preferred to enroll in alternate trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David A. Pistenmaa, MD, Principal investigator, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079793
- Sponsor's protocol ID
- SCCC-09809
- Other IDs
- CDR0000666842
- Status last verified
- Mar 2019
- First submitted
- 2 Mar 2010
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Adjuvant Prostate Irradiation and Ixabepilone For High Risk Prostate Cancer Post-Prostatectomy
- ClinicalTrials.gov ID
- NCT01079793
- Acronym / sponsor ID
- SCCC-09809
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage III prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Overlapping study, PI preferred to enroll in alternate trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 May 2010 (actual)
- Primary completion
- 17 Oct 2011 (actual)
- Study completion
- 17 Oct 2011 (actual)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ixabepilone | Experimental | Drug: ixabepilone, Procedure: adjuvant therapy, Radiation: intensity-modulated radiation therapyAdjuvant therapy |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ixabepilone | Drug | ixabepilone |
| adjuvant therapy | Procedure or surgery | ixabepilone |
| intensity-modulated radiation therapy | Radiation | ixabepilone |
Primary outcome
Dose-limiting toxicity (phase I)
Time frame: 3 years
Dose-limiting toxicity (phase I)
Maximum-tolerated dose (phase I)
Time frame: 3 years
Maximum-tolerated dose (phase I)
Freedom from progression for 3 years (phase II)
Time frame: 3 years
Freedom from progression for 3 years (phase II)
4 secondary outcomes
Time to biochemical, local and distant failure (phase II)
Time frame: 3 years
Disease-specific survival (phase II)
Time frame: 3 years
Overall survival rate (phase II)
Time frame: 3 years
Adverse events as assessed by NCI CTCAE v. 4.0
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A. Pistenmaa, MD principal investigator
Simmons Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ixabepilone, adjuvant therapy and intensity-modulated radiation therapy in people with Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (phase I) (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.