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A Phase II Study of 9 Nitrocamptothecin for Hormone Refractory Prostate Cancer

Phase 2
Not Enrolling
Prostate Cancer

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Trial Information

A Phase II Study of 9 Nitrocamptothecin for Hormone Refractory Prostate Cancer


- Determine the therapeutic efficacy of nitrocamptothecin in patients with metastatic,
hormone refractory prostate cancer.

- Determine time to disease progression and duration of response in this patient
population as a result of this treatment regimen.

- Determine the safety, tolerance, and toxicity of this treatment regimen in these

OUTLINE: Patients receive nitrocamptothecin orally daily for 5 consecutive days each week
for 3 consecutive weeks. Treatment continues every 4 weeks in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 3 months until evidence of progression or relapse for a maximum
of 2 years from the date of registration.

PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study over 2 years.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate with clinically progressive
stage IVA or IVB disease after at least primary androgen ablation with either
orchiectomy or LHRH agonist and only one cytotoxic chemotherapy regimen

- Measurable disease with a maximum of 10 measurable lesions OR nonmeasurable disease

- Serum testosterone no greater than 50 ng/mL if no prior bilateral orchiectomy



- Not specified

Performance status:

- ECOG 0 or 1

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3 (transfusion independent)

- No disseminated intravascular coagulation


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT no greater than 3 times ULN


- Creatinine no greater than 1.5 times ULN


- Fertile patients must use effective contraception

- No currently active second malignancy other than nonmelanoma skin cancers

- No active infection


Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered


- See Disease Characteristics

- At least 6 weeks since prior suramin

- At least 4 weeks since other prior chemotherapy

- No prior therapy with camptothecin or any of its analogues

Endocrine therapy:

- Prior second line hormonal therapy allowed

- At least 4 weeks since prior hormonal therapy

- Concurrent treatment with LHRH agonists allowed and required for

- patients without orchiectomy

- No concurrent hormonal therapy except for nondisease related conditions

- Concurrent corticosteroids allowed if on stable dose for at least 6 weeks

- before study

- No concurrent dexamethasone as an antiemetic


- At least 4 weeks since prior radiotherapy and recovered

- No palliative radiotherapy

- At least 8 weeks since prior strontium 89 or samarium 153


- At least 3 weeks since major surgery and recovered

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Edward P. Gelmann, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lombardi Cancer Research Center


United States: Federal Government

Study ID:




Start Date:

May 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
CCOP - Southwestern Vermont Regional Cancer CenterBennington, Vermont  05201
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Lombardi Cancer Center, Georgetown UniversityWashington, District of Columbia  20007
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722