Estramustine, Docetaxel, and Carboplatin for Patients With Hormone Refractory Prostate Cancer Progressing After Mitoxantrone-Based Chemotherapy.

NCT00183924 | Completed Phase 2 DMC

• 1 other identifier: 4P-01-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is for patients with prostate cancer that is metastatic, progressive, and resistant to hormonal manipulation and mitoxantrone chemotherapy.Patients have previously been treated with surgical removal of the testes or hormone therapy, and subsequently with chemotherapy that included the drug, mitoxantrone (Novantrone). Patients will have prostate cancer that has worsened despite these treatments. We hope to learn whether the combination chemotherapy decreases cancer symptoms and tests, and to determine how frequently serious side effects occur with acceptable toxicity from the chemotherapy.

Conditions

Prostate Adenocarcinoma

Interventions

Estramustine DRUG

Docetaxel DRUG

Carboplatin DRUG

Eligibility Criteria

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

You may qualify if:

• Patient must have had a histological diagnosis of adenocarcinoma of prostate and currently must have metastatic disease (stage TxNxM1) that is unresponsive or refractory to hormone therapy and mitoxantrone-based chemotherapeutic regimens. Patients must have metastatic prostate cancer deemed to be hormone- and mitoxantrone refractory by one or more of the following (despite androgen ablation, anti-androgen withdrawal and mitoxantrone therapy where applicable):
• Progression of measurable disease assessed within 28 days prior to registration.
• Progression of non-measurable (i.e. bone scan or PET scan) disease assessed within 42 days prior to registration.
• Rising PSA - defined as at least 2 consecutive rises in PSA documented over a reference value (measure 1). The first rising PSA (measure 2) should be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater then the second measure and it must be obtained at least 7 days after the 2nd measure. Patient must have a PSA concentration of at least 10 ng/ml in addition to increasing PSA to be eligible based on PSA criteria alone. No minimum PSA is required for patients with measurable disease or non-PSA evaluable disease.
• Age \> 18 years
• Must have received prior hormonal therapy and have a castrate level of testosterone. Patients treated with orchiectomy are eligible. If they have been treated with non-steroidal anti-androgens, the patients must have ceased taking flutamide or nilutamide at least 28 days prior to enrollment and at least 42 days prior to enrollment for bicalutamide, and patients must have demonstrated disease progression. Either method of castration can have been supplemented with nonsteroidal antiandrogen (e.g. flutamide, bicalutamide, nilutamide).
• Must have received prior mitoxantrone therapy
• Prior radiation therapy is allowed but it must have been to less than 25% of total body bone marrow (see Appendix 5). This includes prior use of samarium, but patients cannot have received strontium. (\>28 days must have elapsed since completion of RT with recovery from side effects. Soft tissue disease irradiated in the prior 2 months is not and may not be designated as measurable disease).
• May have received prior surgery (21 days must have elapsed since completion of surgery with recovery from side effects)
• Creatinine less than or equal to 1.5x the institutional upper limit of normal (within 28 days prior to registration)
• Bilirubin less than or equal to the institutional upper limit of normal (within 28 days prior to registration).
• Liver enzymes: If alkaline phosphatase is less than or equal to 4 x institutional upper limit of normal (ULN), then AST and ALT must be less than or equal to 2.0 x ULN. If alkaline phosphatase is \> 4 x ULN in patients with bone metastases, then AST and ALT must be \< 1.25 x ULN.
• Adequate bone marrow function. Complete blood count with differential must be done within 14 days prior to registration
• WBC greater than or equal to 3000 cells/mm3
• Absolute neutrophil count greater than or equal to 1500 cells/mm3

You may not qualify if:

• Myocardial infarction or angina pectoris within one year of registration
• History of brain metastases or currently has treated or untreated brain metastasis. (Patients with neurological symptoms must have CT or MRI brain negative for metastatic disease within 56 days prior to registration)
• Active thrombophlebitis or hypercoagulability.
• Known history of pulmonary embolism or deep venous thrombosis.
• Not recovered from major infections and/or surgical procedures, or has significant active concurrent other medical illness precluding protocol therapy or survival.
• Known or anticipated severe hypersensitivity reaction to estramustine, docetaxel, polysorbate 80 or carboplatin
• Other prior malignancy (except patients who have had another stage I or II malignancy currently in complete remission or other cancer with no evidence of disease for greater than 5 years from accrual to the current trial. Patients with basal or squamous cell carcinoma of the skin that have been treated with curative intent can be accrued to this trial 30 days after treatment).
• Preexistent peripheral neuropathy greater than or equal to grade 2
• Prior therapy with estramustine, taxanes (e.g. paclitaxel, docetaxel) or platinum-based (e.g. cisplatin, carboplatin, oxaliplatin) drugs or ongoing therapy
• Ongoing therapy with drugs known to inhibit P4503A4 drug metabolism including: Macrolide antibiotics: erythromycin, troleandomycin, azithromycin; Calcium antagonists: nifedipine, diltiazem; Imidazole antifungal agents: ketoconazole, itraconazole, fluconazole; HIV protease inhibitors; Immunosuppressive agents: cyclosporin, FK-506
• Ongoing therapy with drugs known to induce P4503A4 drug metabolism including: Phenobarbital, phenytoin, carbamazepine, griseofuvin and rifampin.

Sponsors & Collaborators

• University of Southern California: lead
• Aventis Pharmaceuticals: collaborator

Study Sites (1)

Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Interventions

Estramustine; Docetaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• David Quinn, MD

  University of Southern California

  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: September 9, 2005
• First Posted: September 16, 2005
• Study Start: March 1, 2001
• Primary Completion: July 1, 2006
• Study Completion: December 1, 2008
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (1)