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

NCT01079793 | Withdrawn Phase 1 DMC

• 2 other identifiers: SCCC-09809CDR0000666842
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage III prostate cancer

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity (phase I)

  Dose-limiting toxicity (phase I)

  3 years

• Maximum-tolerated dose (phase I)

  Maximum-tolerated dose (phase I)

  3 years

• Freedom from progression for 3 years (phase II)

  Freedom from progression for 3 years (phase II)

  3 years

Secondary Outcomes (4)

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

  3 years

• Disease-specific survival (phase II)

  3 years

• Overall survival rate (phase II)

  3 years

• Adverse events as assessed by NCI CTCAE v. 4.0

  3 years

Study Arms (1)

ixabepilone

EXPERIMENTAL

Adjuvant therapy

Drug: ixabepilone; Procedure: adjuvant therapy; Radiation: intensity-modulated radiation therapy

Interventions

ixabepilone DRUG

ixabepilone

adjuvant therapy PROCEDURE

ixabepilone

intensity-modulated radiation therapy RADIATION

ixabepilone

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

ixabepilone; Chemotherapy, Adjuvant; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy

Study Officials

• David A. Pistenmaa, MD

  Simmons Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: May 26, 2010
• Primary Completion: October 17, 2011
• Study Completion: October 17, 2011
• Last Updated: August 20, 2020

Record last verified: 2019-03

Locations

US (1)