Cabazitaxel With Radiation and Hormone Therapy for Prostate Cancer

NCT01420250 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: 11D.2432011-32JT 1820
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, non-randomized Phase I study of weekly Cabazitaxel with concurrent intensity modulated radiation therapy (IMRT) (A type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles.) and androgen deprivation therapy (Treatment to suppress or block the production or action of male hormones) in patients with locally advanced prostate cancer. It is hoped that by adding Cabazitaxel to the standard IMRT, greater local disease control can be achieved and eventually the cure rate can be increased. After this study, the maximally tolerated dose of Cabazitaxel that could be used in combination with radiation can be found. Men with locally advanced high risk prostate cancer represent a group of patients for whom cure is potentially achievable utilizing a multimodality approach. More aggressive treatment upfront with chemotherapy and ADT may improve the long term disease control. We hypothesize that Cabazitaxel may be added to radiation therapy safely, and we anticipate that this novel approach will improve disease control and eventually improve survival for locally advanced prostate cancer patients.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

• Maximally Tolerated Dose (MTD) of Cabazitaxel and Intensity Modulated Radiation Therapy (IMRT)

  To determine the maximally tolerated dose, or the safety and feasibility, of the concurrent weekly Cabazitaxel and IMRT with androgen deprivation therapy

  Weekly during treatment then every 3 months until 2 years after completion of IMRT

Secondary Outcomes (2)

• Acute and Late Non-Hematologic and Hematologic Toxicity Profile of Cabazitaxel and Intensity Modulated Radiation Therapy (IMRT) Combination

  Weekly during IMRT, then at 2 weeks and 3 months after IMRT, and then every 3 months until 2 years after IMRT

• 5-Year Biochemical Relapse Free Survival

  Within 5 years after completion of IMRT

Study Arms (1)

Cabazitaxel with Intensity Modulated Radiation Therapy (IMRT)

EXPERIMENTAL

Weekly Cabazitaxel with concurrent IMRT

Drug: Cabazitaxel; Radiation: Intensity Modulated Radiation Therapy (IMRT); Drug: Anti-Androgen Therapy: Bicalutamide; Genetic: Luteinizing Hormone-Releasing Hormone (LHRH) Agonist

Interventions

Cabazitaxel DRUG

Administered weekly on the same day of radiation according to the following infusion levels: Level 1 (Initial): 4 mg/m2; Level -1: 2 mg/m2; Level 2: 6 mg/m2; Level 3: 8 mg/m2; Level 4: 10 mg/2;

Also known as: Jevtana, XRP-6258

Cabazitaxel with Intensity Modulated Radiation Therapy (IMRT)

Intensity Modulated Radiation Therapy (IMRT) RADIATION

Starts 8 weeks after initiation of androgen deprivation therapy, given daily at 1.8 Gy for a total of 75.6 Gy

Also known as: Intensity Modulated Radiation Therapy, IMRT, Radiation therapy

Cabazitaxel with Intensity Modulated Radiation Therapy (IMRT)

Anti-Androgen Therapy: Bicalutamide DRUG

* Taken once daily by mouth starting between 2 weeks and 1 day before the first administration of Luteinizing Hormone-Releasing Hormone (LHRH) * Will continue once daily until the final day of IMRT

Also known as: Casodex, Cosudex, Calutide, Kalumid

Cabazitaxel with Intensity Modulated Radiation Therapy (IMRT)

Luteinizing Hormone-Releasing Hormone (LHRH) Agonist GENETIC

* First administration will occur 1 day to 2 weeks after the start of Bicalutamide and 8 weeks prior to the start of IMRT (+/- 4 weeks) * Will continue for 24 months after IMRT * Total administered duration and agent used must be documented on the case report form

Also known as: Gonadotropin-releasing hormone, GnRH, LHRH, Luliberin

Cabazitaxel with Intensity Modulated Radiation Therapy (IMRT)

Eligibility Criteria

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

You may qualify if:

• Adenocarcinoma of the prostate with locally advanced prostate cancer without distant metastatic with unfavorable risk features that are defined below:
• Gleason score ≥8
• Gleason score 7 and T3/T4 disease
• Gleason score 7 but PSA ≥20
• Karnofsky Performance Status \>70,
• Age \> 18
• Performance Status: ECOG ≤2
• Peripheral neuropathy: must be \< grade 1
• Hematologic (minimal values):
• Absolute neutrophil count \> 1,500/mm3
• Hemoglobin \> 8.0 g/dl
• Platelet count \> 100,000/mm3
• Hepatic function
• Total bilirubin \< Upper limit of normal (ULN)(except for Gilbert's disease)
• AST (SGOT) \< 1.5 x ULN

You may not qualify if:

• Patients with a history of severe hypersensitivity reaction to Cabazitaxel or other drugs formulated with polysorbate 80.
• History of urological surgery or procedures predisposing to GU complications after radiation (will be determined by radiation oncologist)
• History of diverticulitis, rectal bleeding or other lower GI diseases predisposing to GI complications after radiation (will be determined by radiation oncologist)
• History of prior chemotherapy or pelvic irradiation,
• History of prior invasive malignant cancer(s) within the last 5 years except adequately treated or controlled basal cell or squamous cell carcinoma of the skin
• Documented distant metastatic disease.
• Prior radical prostatectomy or cryosurgery for prostate cancer or bilateral orchiectomy

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Sanofi: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospitals

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabazitaxel; XRP6258; Radiotherapy, Intensity-Modulated; Radiotherapy; bicalutamide; Gonadotropin-Releasing Hormone

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)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Therapeutics; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Robert Den, MD

  Thomas Jefferson University

  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: August 17, 2011
• First Posted: August 19, 2011
• Study Start: September 22, 2011
• Primary Completion: July 21, 2015
• Study Completion: July 21, 2020
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)