Phase II Metronomic Dosing, Etoposide, Cyclophosphamide,... | NCT00176605

NCT00176605

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
P30CA072720	U.S. NIH Grant/Contract		View source
0220044931	Other Identifier	IRB Number
CDR0000443482

Status Module

Name	Class
National Cancer Institute (NCI)	NIH
Bristol-Myers Squibb	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1 (Etoposide + Cyclophosphamide)	Experimental	Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy. Total duration of therapy is 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Therapy will continue in this alternating manner for 24 weeks. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.	Drug: Etoposide Drug: Cyclophosphamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Etoposide	Drug	50 mg per day of Etoposide orally for 21 consecutive days. Etoposide will be alternated with oral cyclophosphamide. The drug is administered at night just prior to bed. Week 1 of each cycle will begin with etoposide.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PSA Response Rate	The PSA response rate is the percentage of patients who have a PSA response. A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Patients may not demonstrate clinical or radiographic evidence of disease progression during this period.	5 years

Secondary Outcomes

Measure	Description	Time Frame
Toxicities Related to Chronic Administration of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.	All patients who receive one dose of protocol therapy will be evaluable for toxicity. A total of 15 patients received at least one dose of protocol therapy. Adverse events are described in Adverse Event section.	5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Patients with histologically proven prostate cancer and tumors limited to the prostate (including seminal vesicle involvement, provided all visible disease was surgically removed) that have completed local therapy and have an rising PSA value, as defined in Section 5.1.5.
Prior androgen ablation therapy is allowed as long as the patient completed therapy at least 1 year prior to entry into this study. The patient must be fully recovered from such therapy and must not have demonstrated progression while on androgen ablation therapy.
Primary treatment to the prostate (surgery and/or radiation) must have been completed at least 3 months prior to entry into this study and the patient must be fully recovered from such therapy.
Patients must have a negative CT of the chest, abdomen and pelvis and bone scan. The scans must be completed within 4 weeks prior to the date of starting therapy.
PSA value for patients enrolled must be > 2 ng/ml with a doubling time of £ 12 months. PSA value > 2 ng/ml must be documented by two measurements at least four weeks apart. The final PSA measurement before study entry must be obtained within one week prior to therapy. This will be considered the baseline PSA. (Note: The website http://www.mskcc.org/mskcc/html/10088.cfm may be used to access a prostate normogram calculator.)
The following lab values must be obtained within 4 weeks prior to therapy:
ANC ≥1500/mm³,
Hemoglobin ≥ 10 g/dl
Platelet count ≥ 100,000/mm³
Serum creatinine ≤ 1.5 mg/dL
Total bilirubin ≤ 1.5 mg/dL
Liver function tests (SGOT, SGPT) ≤ 1.5 times the upper limit of the institution's normal range.
Men ≥ 18 years of age.
An estimated life expectancy of at least 6 months.
ECOG performance status ≤ 2.
Able to give informed, written consent.
Men must consent to using effective contraception (barrier method- latex condom) while on treatment and for 4 weeks after discontinuation of treatment.

Exclusion Criteria

Patients with active infections or known infection with HIV (HIV testing will not be performed as part of this study).
Any coexisting medical condition including uncontrolled cardiac, hepatic, renal or psychiatric disease defined as ³ Grade 3 (CTCAE Version 3).
Concurrent use of other investigational agent.
Patients that have previously received more than 2 months of therapy with any of the agents used in this study.
PSA value < 2 ng/ml.
Prior chemotherapy in the past 5 years.
Use of androgen ablation therapy within 1 year, or history of progression on androgen ablation therapy.

Name	Affiliation	Role
Mark Stein, MD	Rutgers, The State University of New Jersey	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Central Jersey Oncology Center		East Brunswick	New Jersey	08816	United States
Robert Wood Johnson University Hospital/CINJ at Hamilton

Arm/Group Information

ID	Title	Description
FG000	Arm 1 (Etoposide + Cyclophosphamide)	Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide. Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Arm 1 (Etoposide + Cyclophosphamide)	Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide. Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

PSA Response Rate

The PSA response rate is the percentage of patients who have a PSA response. A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Patients may not demonstrate clinical or radiographic evidence of disease progression during this period.

Posted

Number

percentage of participants

5 years

ID	Title	Description
OG000	Arm 1 (Etoposide + Cyclophosphamide)	Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide. Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm 1 (Etoposide + Cyclophosphamide)	Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide. Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Valvular heart disease	Cardiac disorders	CTCAE (3.0)	Systematic Assessment	Patient admitted for sycopy. Cardiac workup showed critical aortic valve stenosis. Unlikely related to protocol.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons