Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer

NCT01750866 | Withdrawn Phase 2 DMC

• 2 other identifiers: CASE3811NCI-2012-02993
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cabazitaxel is already approved by the Food and Drug Administration (FDA) for use in patients with advanced prostrate cancer, following docetaxel therapy. The purpose of this study is to better understand the response and toxicity of cabazitaxel of elderly men (age 75 years and older) with advanced prostate cancer who have progressed during or after treatment with docetaxel. All patients on this study will receive cabazitaxel by intravenous (through a vein) infusion plus prednisone by mouth twice daily, and following the chemotherapy infusions, an injection of a granulocyte colony-stimulating factor (G-CSF). G-CSF will help the body produce more white blood cells, which should help decrease the risk of getting an infection while being treated with cabazitaxel.

Conditions

Castrate-resistant Metastatic Prostate Cancer

Keywords

Prostrate Cancer; Castrate-resistant metastatic prostate cancer; Cabazitaxel

Outcome Measures

Primary Outcomes (1)

• Number of patients progression-free survival after completion of treatment.

  Treatment will continue until disease progression, intolerable side effects, or a maximum of 10 cycles of therapy. Progression-free survival defined as PSA progression, tumor progression in patients with measurable disease, or death.

  at end of treatment (up to 30 weeks)

Secondary Outcomes (3)

• Number of patients that experience treatment-emergent adverse events

  at end of each treatment cycle (up to 30 weeks)

• Number of patients with a prostate-specific antigen (PSA) response

  at end of each treatment cycle (up to 30 weeks)

• Change in geriatric assessments from baseline to end of therapy

  every 2 cycles of therapy (6 weeks) up to 30 weeks

Other Outcomes (2)

• Change in circulating tumor cells (CTC) from baseline

  at end of treatment (up to 30 weeks)

• Change in biomarkers from baseline

  at 3 weeks (after one cycle)

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

Cabazitaxel 25 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. Treatment will continue until disease progression, intolerable side effects, or a maximum of 10 cycles of therapy.

Drug: Cabazitaxel; Drug: Prednisone; Drug: Granulocyte colony-stimulating factor (G-CSF)

Interventions

Cabazitaxel DRUG

Cabazitaxel 25 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.

Also known as: taxoid XRP6258, Jevtana, RPR-116258A, XRP6258

Cabazitaxel

Prednisone DRUG

Prednisone 10 mg on Day 1 of the first cycle and continue taking 10 mg po daily for the entire cycle.

Cabazitaxel

Granulocyte colony-stimulating factor (G-CSF) DRUG

Granulocyte colony stimulating factor (Neulasta 6 mg sc) with each cycle, starting with the first cycle, to minimize the risk of complications from neutropenia.

Cabazitaxel

Eligibility Criteria

• Age: 75 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Histologically proven, castrate-resistant metastatic prostate cancer without neuroendocrine differentiation or small cell histology
• Age ≥ 75 years of age
• Progressive disease despite:
• Previous therapy with docetaxel
• Progressive disease for study enrollment is defined by either:
• PSA criteria according to the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria with a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination and a PSA at the screening visit of ≥ 2 ng/ml
• Radiographic progression in soft tissue according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
• Appearance of two or more lesions on a bone
• Previous treatment with abiraterone acetate or enzalutamide is allowed, but last dose must be at least 14 days prior to enrollment in this trial.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Ongoing androgen deprivation with a serum testosterone \< 50 ng/dL
• A score of 8-14 on the Mini Nutritional Assessment (MNA) (normal nutritional status or at risk of malnutrition). MNA in Appendix 4 and available at www.mna-elderly.com.
• Patients must have the following laboratory values:
• Hematologic:
• Absolute Neutrophil Count (ANC) \>/=1.5x109/L

You may not qualify if:

• History of severe hypersensitivity reaction (≥grade 3) to docetaxel and polysorbate 80 containing drugs
• Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
• Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments)
• Previous treatment with cabazitaxel
• Patients with Central Nervous System (CNS) metastasis. Patients without clinical signs or symptoms of CNS involvement are not required to have a CT/MRI of the brain
• Clinically significant cardiac disease within 6 months, including myocardial infarction, New York Heart Association (NYHA) Class III or IV heart disease, or left ventricular ejection fraction of \< 50% at baseline for patients with a history of congestive heart failure.
• History of another malignancy in the previous 5 years with the exception of curatively treated non-melanomatous skin cancer.
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness due to potential pharmacokinetic interactions of therapy with cabazitaxel.
• Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial.
• Unresolved toxicities from previous chemotherapy which has not resolved to ≤ grade 1 by CTCAE Version 4.02 criteria with the exception of alopecia or grade 2 peripheral neuropathy.
• Major surgery ≤ 2 weeks prior to the start of the study or who have not recovered from a previous surgery. (Placement of a venous access device within 2 weeks is permitted)

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

MeSH Terms

Interventions

cabazitaxel; XRP6258; Prednisone; Granulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Dale Shepard, Md, PhD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 17, 2012
• Study Start: February 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10