Etoposide and Cyclophosphamide in Treating Patients With Stage D0 Prostate Cancer
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Purpose
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 |
|---|---|---|
|
Prostate Cancer |
Drug: cyclophosphamide Drug: etoposide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer |
- Prostate-specific antigen response [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 39 |
| Study Start Date: | May 2005 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine the prostate-specific antigen response in patients with stage D0 prostate cancer treated with low-dose etoposide and cyclophosphamide.
Secondary
- Determine the toxic effects of this regimen in these patients.
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.
Eligibility| 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
- Seminal vesicle involvement allowed provided all visible disease was removed by surgery
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
- Final PSA measurement must be obtained within 1 week prior to study entry
Negative CT scan of the chest, abdomen, and pelvis and bone scan
- Scans must be completed within 4 weeks prior to study entry
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 6 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
Hepatic
- SGOT and SGPT ≤ 1.5 times upper limit of normal
- Bilirubin ≤ 1.5 mg/dL
- No uncontrolled hepatic disease
Renal
- Creatinine ≤ 1.5 mg/dL
- No uncontrolled renal disease
Cardiovascular
- No uncontrolled cardiac disease
Other
- Fertile patients must use effective barrier contraception during and for 4 weeks after completion of study treatment
- No active infection
- No known HIV positivity
- No other uncontrolled medical condition, defined as ≥ grade 3
- No uncontrolled psychiatric disease
- No diagnosis of major depression or suicidal ideation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 5 years since prior chemotherapy
- No prior treatment with cyclophosphamide or etoposide that lasted for > 2 months
Endocrine therapy
At least 1 year since prior androgen-ablation therapy and recovered
- No disease progression during therapy
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
Surgery
- See Disease Characteristics
- Recovered from prior surgery
Other
- No other concurrent investigational agents
- No concurrent cyclosporine, succinylcholine chloride, or phenobarbital
Contacts and Locations| United States, New Jersey | |
| Central Jersey Oncology Center, PA - East Brunswick | |
| East Brunswick, New Jersey, United States, 08816 | |
| Cancer Institute of New Jersey at Hamilton | |
| Hamilton, New Jersey, United States, 08690 | |
| Mountainside Hospital Cancer Center | |
| Montclair, New Jersey, United States, 07042 | |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | |
| Morristown, New Jersey, United States, 07962 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Saint Peter's University Hospital | |
| New Brunswick, New Jersey, United States, 08903 | |
| Overlook Hospital | |
| Summit, New Jersey, United States, 07901 | |
| Study Chair: | Mark Stein, MD | Cancer Institute of New Jersey |
More Information
Additional Information:
No publications provided
| Responsible Party: | Mark Stein, Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School |
| ClinicalTrials.gov Identifier: | NCT00227643 History of Changes |
| Other Study ID Numbers: | CDR0000443482, P30CA072720, CINJ-080408-4931 |
| Study First Received: | September 26, 2005 |
| Last Updated: | November 12, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
recurrent prostate cancer stage IV prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Cyclophosphamide Etoposide phosphate Etoposide Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013