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CompletedNCT00005820Updated Jul 13, 2016

Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy

A Phase 2 interventional study of nitrocamptothecin in Prostate Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 50 sites in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2016-07-13.

Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Sex
Male
01

Study summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating men who have stage IV prostate cancer that has not responded to hormone therapy.

Read the detailed description

OBJECTIVES:

  • 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 patients.

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.

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Conditions studied

  • Prostate Cancer

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Keywords

  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.

This study's enrollment of 35 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • ECOG 0 or 1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3 (transfusion independent)
  • No disseminated intravascular coagulation

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 3 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • Fertile patients must use effective contraception
  • No currently active second malignancy other than nonmelanoma skin cancers
  • No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

  • 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

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • No palliative radiotherapy
  • At least 8 weeks since prior strontium 89 or samarium 153

Surgery:

  • At least 3 weeks since major surgery and recovered
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    nitrocamptothecin

    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.

    Drug: nitrocamptothecin

Interventions

  • Drugnitrocamptothecin
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What researchers measure

Primary outcomes

  1. median time to disease and PSA progression

    Time frame: Up to 2 years

Secondary outcomes

  1. overall survival

    Time frame: Up to 2 years

07

Study locations

50 sites
  • Veterans Affairs Medical Center - Birmingham
    Birmingham, Alabama 35233, United States
  • University of California San Diego Cancer Center
    La Jolla, California 92093-0658, United States
  • UCSF Cancer Center and Cancer Research Institute
    San Francisco, California 94115-0128, United States
  • Veterans Affairs Medical Center - San Francisco
    San Francisco, California 94121, United States
  • CCOP - Christiana Care Health Services
    Wilmington, Delaware 19899, United States
  • Lombardi Cancer Center, Georgetown University
    Washington, District of Columbia 20007, United States
  • Walter Reed Army Medical Center
    Washington, District of Columbia 20307-5000, United States
  • CCOP - Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
  • University of Illinois at Chicago Health Sciences Center
    Chicago, Illinois 60612, United States
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)
    Chicago, Illinois 60612, United States
  • University of Chicago Cancer Research Center
    Chicago, Illinois 60637, United States
  • Hematology Oncology Associates of the Quad Cities
    Bettendorf, Iowa 52722, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • Veterans Affairs Medical Center - Togus
    Togus, Maine 04330, United States
  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland
    Baltimore, Maryland 21201, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • University of Massachusetts Memorial Medical Center
    Worcester, Massachusetts 01655, United States
  • Veterans Affairs Medical Center - Minneapolis
    Minneapolis, Minnesota 55417, United States
  • University of Minnesota Cancer Center
    Minneapolis, Minnesota 55455, United States
  • Veterans Affairs Medical Center - Columbia (Truman Memorial)
    Columbia, Missouri 65201, United States
  • Ellis Fischel Cancer Center - Columbia
    Columbia, Missouri 65203, United States
  • Barnes-Jewish Hospital
    Saint Louis, Missouri 63110, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198-3330, United States
  • CCOP - Southern Nevada Cancer Research Foundation
    Las Vegas, Nevada 89106, United States
  • Norris Cotton Cancer Center
    Lebanon, New Hampshire 03756, United States
  • Veterans Affairs Medical Center - Buffalo
    Buffalo, New York 14215, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263-0001, United States
  • CCOP - North Shore University Hospital
    Manhasset, New York 11030, United States
  • North Shore University Hospital
    Manhasset, New York 11030, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10021, United States
  • New York Presbyterian Hospital - Cornell Campus
    New York, New York 10021, United States
  • Mount Sinai Medical Center, NY
    New York, New York 10029, United States
  • State University of New York - Upstate Medical University
    Syracuse, New York 13210, United States
  • Veterans Affairs Medical Center - Syracuse
    Syracuse, New York 13210, United States
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    Syracuse, New York 13217, United States
  • Lineberger Comprehensive Cancer Center, UNC
    Chapel Hill, North Carolina 27599-7295, United States
  • Veterans Affairs Medical Center - Durham
    Durham, North Carolina 27705, United States
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
  • CCOP - Southeast Cancer Control Consortium
    Winston-Salem, North Carolina 27104-4241, United States
  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
    Winston-Salem, North Carolina 27157-1082, United States
  • Arthur G. James Cancer Hospital - Ohio State University
    Columbus, Ohio 43210, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425-0721, United States
  • University of Tennessee, Memphis Cancer Center
    Memphis, Tennessee 38103, United States
  • Veterans Affairs Medical Center - Memphis
    Memphis, Tennessee 38104, United States
  • CCOP - Southwestern Vermont Regional Cancer Center
    Bennington, Vermont 05201, United States
  • Vermont Cancer Center
    Burlington, Vermont 05401-3498, United States
  • Veterans Affairs Medical Center - White River Junction
    White River Junction, Vermont 05009, United States
  • Veterans Affairs Medical Center - Richmond
    Richmond, Virginia 23249, United States
  • MBCCOP - Massey Cancer Center
    Richmond, Virginia 23298-0037, United States
08

References and documents

Publications

  • Amin A, Halabi S, Gelmann EP, Stadler W, Vogelzang N, Small E. 9-Nitrocamptothecin as second line chemotherapy for men with progressive, metastatic, hormone refractory prostate cancer: Results of the CALGB 99901. Urol Oncol. 2004 Sep-Oct;22(5):398-403. doi: 10.1016/j.urolonc.2004.05.002. PubMed 15464920 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00005820
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 12, 2004
Start date
May 2000
Primary completion
Sep 2004
Completion
Sep 2006
Last update
Jul 13, 2016

Study contacts

Edward P. Gelmann, MD
study chair · Lombardi Comprehensive Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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