Prostate CancerPhase 2NCT00003626
Dolastatin 10 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Hormone Therapy
A Phase 2 study testing dolastatin 10 in people with Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute at 3 sites in United States.
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 dolastatin 10 in treating patients with metastatic prostate cancer that has not responded to previous 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?
- dolastatin 10
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Oct 1998to May 2000
- 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: Hormone refractory metastatic prostate cancer (stage D1 or D2) with no greater than 3 prior endocrine manipulations PSA level increased on 3 consecutive measurements at least 2 weeks apart PSA at least 10 ng/mL (not required if measurable disease)
PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Hemoglobin at least 8 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2 mg/dL AST no greater than 2 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Other: No other serious medical illness No serious infection No other prior malignancy within the past 5 years except nonmelanoma skin cancer or any in situ carcinoma
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: See Disease Characteristics Concurrent LHRH-agonist therapy allowed without antiandrogens At least 4 weeks since prior flutamide and nilutamide At least 6 weeks since prior bicalutamide At least 4 weeks since other prior hormone therapy including steroids Radiotherapy: At least 4 weeks since prior radiation therapy and recovered No prior strontium Surgery: Recovered from prior surgery
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Cancer Center
Denver, Colorado, 80262
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Phase II Evaluation of Dolastatin-10 in Patients With 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 dolastatin 10 in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy.
Read the detailed description
OBJECTIVES: I. Determine the objective response rate in patients with hormone refractory prostate cancer treated with dolastatin 10. II. Determine the toxicity of this regimen in this patient population.
OUTLINE: Patients receive dolastatin 10 IV bolus every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- dolastatin 10
- Keywords
- 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.
dolastatin 10Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2004 (estimated)
- Study startOct 1998
- Primary completionDec 1999
- Study completionMay 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Maha Hadi A. Hussain, MD, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003626
- Sponsor's protocol ID
- CDR0000066708
- Other IDs
- P30CA022453, WSU-D-1644, NCI-T98-0019
- Status last verified
- Apr 2013
- First submitted
- 1 Nov 1999
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vaishampayan U, Glode M, Du W, Kraft A, Hudes G, Wright J, Hussain M. Phase II study of dolastatin-10 in patients with hormone-refractory metastatic prostate adenocarcinoma. Clin Cancer Res. 2000 Nov;6(11):4205-8.
PubMed 11106233
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of Dolastatin-10 in Patients With Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00003626
- Acronym / sponsor ID
- CDR0000066708
- Conditions
- Prostate Cancer
- Keywords
- stage IV prostate cancer, recurrent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 1998
- Primary completion
- Dec 1999 (actual)
- Study completion
- May 2000 (actual)
- First posted
- 17 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 dolastatin 10 in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy.
Detailed description
OBJECTIVES: I. Determine the objective response rate in patients with hormone refractory prostate cancer treated with dolastatin 10. II. Determine the toxicity of this regimen in this patient population.
OUTLINE: Patients receive dolastatin 10 IV bolus every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dolastatin 10 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
- Results publication: PubMed 11106233Vaishampayan U, Glode M, Du W, Kraft A, Hudes G, Wright J, Hussain M. Phase II study of dolastatin-10 in patients with hormone-refractory metastatic prostate adenocarcinoma. Clin Cancer Res. 2000 Nov;6(11):4205-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha Hadi A. Hussain, MD study chair
Barbara Ann Karmanos Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dolastatin 10 in people with Prostate Cancer, run by Barbara Ann Karmanos Cancer Institute at 3 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 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003626, which also lists 1 linked publication.
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 5 Apr 2013.