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Prostate CancerPhase 2NCT00005820

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

A Phase 2 study testing nitrocamptothecin in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 50 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Any age, men only
Conditions the study is for
Prostate Cancer
What is being tested?
nitrocamptothecin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
50 sitesUnited States
Study dates
May 2000to Sep 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • CCOP - Southwestern Vermont Regional Cancer Center

    Bennington, Vermont, 05201

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Veterans Affairs Medical Center - Birmingham

    Birmingham, Alabama, 35233

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • University of Illinois at Chicago Health Sciences Center

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637

  • Veterans Affairs Medical Center - Columbia (Truman Memorial)

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina, 27705

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of California San Diego Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • North Shore University Hospital

    Manhasset, New York, 11030

  • University of Tennessee, Memphis Cancer Center

    Memphis, Tennessee, 38103

  • Veterans Affairs Medical Center - Memphis

    Memphis, Tennessee, 38104

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York, 10021

  • Mount Sinai Medical Center, NY

    New York, New York, 10029

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-3330

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Veterans Affairs Medical Center - Richmond

    Richmond, Virginia, 23249

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94115-0128

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13217

  • Veterans Affairs Medical Center - Togus

    Togus, Maine, 04330

  • Lombardi Cancer Center, Georgetown University

    Washington D.C., District of Columbia, 20007

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Veterans Affairs Medical Center - White River Junction

    White River Junction, Vermont, 05009

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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

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.

Conditions
Prostate Cancer
Being tested
nitrocamptothecin
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nitrocamptothecinDrug

Study groups in NCT00005820
Study groupRoleWhat they receive
nitrocamptothecinExperimentalPatients 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.
Receives: Drug: nitrocamptothecin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. median time to disease and PSA progression

    Measured: Up to 2 years

Secondary outcomes (1)

  1. overall survival

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2004 (estimated)
  2. Study startMay 2000
  3. Primary completionSep 2004
  4. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005820
Sponsor's protocol ID
CALGB-99901
Other IDs
U10CA031946, CLB-99901, GUMC-00192, CDR0000067827
Status last verified
Jul 2016
First submitted
2 Jun 2000
Last updated
13 Jul 2016
Results posted
No
Data monitoring committee
No

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

  • Manoharan RK, Han KI, Lee Y, Baek S, Moon E, Park YB, Cho J, Chaudhary J, Shin HD. Gut health and microbiome modulation by the heat-killed postbiotic beLP1(R) in adults with excess weight: a randomized, placebo-controlled trial. Front Nutr. 2026 Sep 17;13:1919277. doi: 10.3389/fnut.2026.1919277. eCollection 2026.

    PubMed 42824179

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nitrocamptothecin in people with Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 50 sites in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

median time to disease and PSA progression (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005820, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.

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