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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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

Other trials in United States

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 groups in NCT01079793
Study groupRoleWhat they receive
ixabepiloneExperimentalAdjuvant 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.

  1. Dose-limiting toxicity (phase I)

    Dose-limiting toxicity (phase I)

    Measured: 3 years

  2. Maximum-tolerated dose (phase I)

    Maximum-tolerated dose (phase I)

    Measured: 3 years

  3. Freedom from progression for 3 years (phase II)

    Freedom from progression for 3 years (phase II)

    Measured: 3 years

Secondary outcomes (4)
  1. Time to biochemical, local and distant failure (phase II)

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

    Measured: 3 years

  2. Disease-specific survival (phase II)

    Disease-specific survival (phase II)

    Measured: 3 years

  3. Overall survival rate (phase II)

    Overall survival rate (phase II)

    Measured: 3 years

  4. 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.

  1. First posted3 Mar 2010 (estimated)
  2. Study start26 May 2010
  3. Primary completion17 Oct 2011
  4. Study completion17 Oct 2011

Why it stopped: Overlapping study, PI preferred to enroll in alternate trial.

Resources

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)
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

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.

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