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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00227643 |
RATIONALE: Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Etoposide and cyclophosphamide may also stop the growth of prostate cancer by blocking blood flow to the tumor. Giving etoposide together with cyclophosphamide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving etoposide together with cyclophosphamide works in treating patients with stage D0 prostate cancer (stage IV prostate cancer that is seen only in the prostate after treatment) .
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: cyclophosphamide Drug: etoposide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer |
Estimated Enrollment: | 39 |
Study Start Date: | May 2005 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive low-dose oral etoposide once daily on days 1-21 and low-dose oral cyclophosphamide once daily on days 22-42. Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 8-12 weeks until disease progression.
PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Stage D0 disease
Disease limited to the prostate
Rising prostate-specific antigen (PSA) after completing primary local therapy (surgery and/or radiotherapy) for prostate cancer ≥ 3 months ago
PSA ≥ 2 ng/mL documented by 2 measurements taken ≥ 4 weeks apart with a doubling time of ≤ 8 months
Negative CT scan of the chest, abdomen, and pelvis and bone scan
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
At least 1 year since prior androgen-ablation therapy and recovered
Radiotherapy
Surgery
Other
United States, New Jersey | |
Cancer Institute of New Jersey at Hamilton | |
Hamilton, New Jersey, United States, 08690 | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
New Brunswick, New Jersey, United States, 08903 | |
Carol G. Simon Cancer Center at Morristown Memorial Hospital | |
Morristown, New Jersey, United States, 07962 | |
Saint Peter's University Hospital | |
New Brunswick, New Jersey, United States, 08903 | |
Overlook Hospital | |
Summit, New Jersey, United States, 07901 | |
Mountainside Hospital Cancer Center | |
Montclair, New Jersey, United States, 07042 |
Study Chair: | Mark Stein, MD | Cancer Institute of New Jersey |
Responsible Party: | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( Mark Stein ) |
Study ID Numbers: | CDR0000443482, CINJ-080408-4931 |
Study First Received: | September 26, 2005 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00227643 |
Health Authority: | United States: Federal Government |
recurrent prostate cancer stage IV prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Cyclophosphamide Genital Diseases, Male |
Etoposide phosphate Etoposide Prostatic Neoplasms Recurrence |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Neoplasms |
Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |