Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer

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Primary Purpose

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

docetaxel

estramustine phosphate sodium

mitoxantrone hydrochloride

prednisone

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Failure of complete androgen ablation (orchiectomy or LHRH and antiandrogen therapy) as manifested by at least 1 of the following criteria: Rise in serum PSA greater than 50% of nadir confirmed on 2 measurements 1 week apart Appearance of new lesions on bone scan Appearance of new soft-tissue lesions Measurable or evaluable disease No brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN SGOT and SGPT no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Cardiovascular: No history of coagulopathy No myocardial infarction in the last 6 months No history of cardiovascular accident No history of congestive heart failure Neurological: No symptomatic peripheral neuropathy greater than grade 1 No history of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures Pulmonary: No history of pulmonary embolus Other: Testosterone no greater than 3.5 nmol/L No contraindications to glucocorticoid therapy such as uncontrolled diabetes mellitus or active peptic ulcer disease No active infection No other serious illness or medical condition No other concurrent or prior malignancy in the past 5 years except previously excised or curatively irradiated nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics At least 4 weeks since prior hormonal therapy (including nonsteroidal antiandrogens, but not LHRH agonists) Radiotherapy: No prior radiotherapy to greater than 30% of bone marrow At least 6 weeks since isotope therapy At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since prior investigational drugs

Sites / Locations

Herbert Irving Comprehensive Cancer Center at Columbia University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003633

First Posted

November 1, 1999

Last Updated

December 18, 2013

Sponsor

Herbert Irving Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00003633

Brief Title

Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer

Official Title

Treatment of Prostate Cancer by Induction of Alternate Cell Death Pathways: A Phase I Trial of Docetaxel, Estramustine, Mitoxantrone and Prednisone

Study Type

Interventional

2. Study Status

Record Verification Date

March 2005

Overall Recruitment Status

Unknown status

Study Start Date

August 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Herbert Irving Comprehensive Cancer Center

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with advanced prostate cancer.

Detailed Description

OBJECTIVES: Determine the maximum tolerated doses of docetaxel and mitoxantrone in combination with a fixed dose of estramustine and prednisone, when given to patients with advanced prostate cancer. Characterize the toxicity of this treatment regimen in these patients. OUTLINE: This is a dose escalation study of mitoxantrone and docetaxel. Patients are stratified into one of two risk groups (good risk group or poor risk group) based on the number of prior chemotherapy regimen(s) and the occurrence and sites(s) of prior radiation. All patients receive oral prednisone twice daily on days 0-3, oral estramustine three times daily on days 1-5, mitoxantrone IV bolus on day 2, and docetaxel IV over 1 hour on day 2. Courses repeat every 21 days in the absence of unacceptable toxicity and disease progression. Patients with stable disease may go off treatment after 6 courses. Dose escalation proceeds independently for each risk group. Cohorts of 3 patients are entered into each risk group. If 1 of 3 patients at a dose level experiences dose limiting toxicity (DLT), then 3 additional patients are accrued into this level. If 2 of 6 patients at a dose level experience DLT, then dose escalation stops and the maximum tolerated dose (MTD) is defined at the previous dose level. At least 6 patients must be treated at the MTD. Patients are followed every 3 months until death. PROJECTED ACCRUAL: At least 12 patients (6 in each risk group) will be accrued into this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

docetaxel

Intervention Type

Drug

Intervention Name(s)

estramustine phosphate sodium

Intervention Type

Drug

Intervention Name(s)

mitoxantrone hydrochloride

Intervention Type

Drug

Intervention Name(s)

prednisone

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Failure of complete androgen ablation (orchiectomy or LHRH and antiandrogen therapy) as manifested by at least 1 of the following criteria: Rise in serum PSA greater than 50% of nadir confirmed on 2 measurements 1 week apart Appearance of new lesions on bone scan Appearance of new soft-tissue lesions Measurable or evaluable disease No brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN SGOT and SGPT no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Cardiovascular: No history of coagulopathy No myocardial infarction in the last 6 months No history of cardiovascular accident No history of congestive heart failure Neurological: No symptomatic peripheral neuropathy greater than grade 1 No history of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures Pulmonary: No history of pulmonary embolus Other: Testosterone no greater than 3.5 nmol/L No contraindications to glucocorticoid therapy such as uncontrolled diabetes mellitus or active peptic ulcer disease No active infection No other serious illness or medical condition No other concurrent or prior malignancy in the past 5 years except previously excised or curatively irradiated nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics At least 4 weeks since prior hormonal therapy (including nonsteroidal antiandrogens, but not LHRH agonists) Radiotherapy: No prior radiotherapy to greater than 30% of bone marrow At least 6 weeks since isotope therapy At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since prior investigational drugs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel P. Petrylak, MD

Organizational Affiliation

Herbert Irving Comprehensive Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Herbert Irving Comprehensive Cancer Center at Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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