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Phase I Trial of Weekly Cabazitaxel With Concurrent Intensity Modulated Radiation Therapy and Androgen Deprivation Therapy for the Treatment of Locally Advanced High Risk Adenocarcinoma of the Prostate


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase I Trial of Weekly Cabazitaxel With Concurrent Intensity Modulated Radiation Therapy and Androgen Deprivation Therapy for the Treatment of Locally Advanced High Risk Adenocarcinoma of the Prostate


Patients with locally advanced high Gleason grade prostate cancer often have local and
metastatic disease progression. To improve on these outcomes, therapy needs to be directed
at controlling the androgen sensitive and insensitive prostate cancer cells in the primary
and metastatic sites. This therapeutic challenge has further prompted the use of combined
modality approaches incorporating chemotherapy and hormonal therapy with radiation aimed at
the intrinsically resistant cells and the micrometastatic disease that are both androgen
sensitive and resistant. High likelihood of occult metastatic disease and existence of
intrinsically castration resistant cells are the main rationales for early institution of
androgen deprivation therapy (ADT) and chemotherapy in prostate cancer.

The rationale for combining chemotherapeutic agents with ADT and radiotherapy in high risk
prostate cancer patients is based on that chemotherapy can enhance radiotherapy and is also
an effective therapy for metastatic castrate resistant disease. Prior studies with weekly
docetaxel with ADT and intensity modulated radiation therapy (IMRT) were safe and feasible
however cabazitaxel is more potent mitotic inhibitor which may further enhance the outcomes
of patients with locally advanced prostate cancer.

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 would 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.

The safety of the combination of Cabazitaxel with radiation will be established after this
study. Potential efficacy will be determined in the future phase II/III trials. Hypofraction
radiation treatment with shorter duration maybe possible if combined with chemotherapy
modality.


Inclusion Criteria:



- 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

- ALT (SGPT) < 1.5 x ULN

- Creatinine < 1.5 x ULN

- Men of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months thereafter.

- No history of previous chemotherapy or pelvic irradiation

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Jianqing Lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University

Authority:

United States: Food and Drug Administration

Study ID:

11D.243

NCT ID:

NCT01420250

Start Date:

September 2011

Completion Date:

September 2018

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Adenocarcinoma of the prostate
  • Adenocarcinoma
  • Prostatic Neoplasms

Name

Location

Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541