Prostate CancerPhase 2NCT00003259
Vinorelbine in Treating Patients With Metastatic Prostate Cancer
A Phase 2 study testing vinorelbine tartrate in people with Prostate Cancer, run by Swiss Cancer Institute at 10 sites in Switzerland.
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 vinorelbine in treating patients with metastatic prostate cancer that has not responded to hormone therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- vinorelbine tartrate
- How many people
- 40 participants
- Where
- 10 sitesSwitzerland
- Study dates
- Oct 1997to Sep 1999
- 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 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic stage IV prostate cancer Proven hormonal resistance Measurable or evaluable disease PSA at least 3 times upper limit of normal No leptomeningeal or brain metastases
PATIENT CHARACTERISTICS: Age: 18 to 85 Performance status: WHO 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: WBC at least 3500/mm3 OR Granulocyte count at least 2000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No acute severe infections No other neoplastic diseases except curatively treated basal cell or squamous cell carcinoma of the skin, or relapse free for more than 5 years after curative treatment of a neoplasm
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytostatic chemotherapy Endocrine therapy: At least 1 month since antiandrogens Prior hormonal therapy required Radiotherapy: No radiotherapy within the past 4 weeks No radiotherapy to the lesions used to evaluate activity of the study drug Surgery: Prior orchiectomy allowed Other: No other investigational drugs during the last month No prior therapy with cytostatic agents
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Switzerland10 sites
Kantonspital Aarau
Aarau, 5001
Office of Walter Weber-Stadelman
Basel, CH 4051
University Hospital
Basel, CH-4031
Inselspital, Bern
Bern, CH-3010
Hopital Cantonal Universitaire de Geneva
Geneva, CH-1211
Istituto Oncologico della Svizzera Italiana
Lugano, CH-6900
Kantonsspital - Saint Gallen
Sankt Gallen, CH-9007
Burgerspital, Solothurn
Solothurn, 4500
City Hospital Triemli
Zurich, 8063
Klinik Hirslanden
Zurich, CH-8008
About this study
Official title: Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma Phase II Trials Protocol 4: Vinorelbine
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 vinorelbine in treating patients with metastatic prostate cancer that has not responded to hormone therapy.
Read the detailed description
OBJECTIVES: I. Evaluate the efficacy of vinorelbine in patients with metastatic hormone-resistant prostate cancer. II. Evaluate the toxicity of vinorelbine in these patients. III. Evaluate the quality of life of these patients, and correlate quality of life with PSA response.
OUTLINE: Patients receive a 5-10 minute intravenous infusion of vinorelbine on day 1 and day 8 of a 21-day course. Patients with stabilization of their disease, partial response, or complete response, receive a maximum of 12 courses of treatment. Patients showing disease progression or severe toxic side effects discontinue treatment. Quality of life and pain are assessed prior to treatment, at days 1 and 8 of each course, and at end of the treatment. Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 14-40 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- vinorelbine tartrate
- Keywords
- stage IV 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.
vinorelbine tartrateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2004 (estimated)
- Study startOct 1997
- Primary completionSep 1999
- Study completionSep 1999
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
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rudolf Morant, MD, Study chair, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003259
- Sponsor's protocol ID
- SAKK 08/97
- Other IDs
- SWS-SAKK-08/97, EU-97042
- Status last verified
- Jun 2019
- First submitted
- 1 Nov 1999
- Last updated
- 26 Jun 2019
- Results posted
- No
Publications
Morant R, Hsu Schmitz SF, Bernhard J, Thurlimann B, Borner M, Wernli M, Egli F, Forrer P, Streit A, Jacky E, Hanselmann S, Bauer J, Hering F, Schmid HP. Vinorelbine in androgen-independent metastatic prostatic carcinoma--a phase II study. Eur J Cancer. 2002 Aug;38(12):1626-32. doi: 10.1016/s0959-8049(02)00145-4.
PubMed 12142053
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma Phase II Trials Protocol 4: Vinorelbine
- ClinicalTrials.gov ID
- NCT00003259
- Acronym / sponsor ID
- SAKK 08/97
- Conditions
- Prostate Cancer
- Keywords
- stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- Oct 1997
- Primary completion
- Sep 1999 (actual)
- Study completion
- Sep 1999 (actual)
- First posted
- 2 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 vinorelbine in treating patients with metastatic prostate cancer that has not responded to hormone therapy.
Detailed description
OBJECTIVES: I. Evaluate the efficacy of vinorelbine in patients with metastatic hormone-resistant prostate cancer. II. Evaluate the toxicity of vinorelbine in these patients. III. Evaluate the quality of life of these patients, and correlate quality of life with PSA response.
OUTLINE: Patients receive a 5-10 minute intravenous infusion of vinorelbine on day 1 and day 8 of a 21-day course. Patients with stabilization of their disease, partial response, or complete response, receive a maximum of 12 courses of treatment. Patients showing disease progression or severe toxic side effects discontinue treatment. Quality of life and pain are assessed prior to treatment, at days 1 and 8 of each course, and at end of the treatment. Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 14-40 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| vinorelbine tartrate | 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 26 Jun 2019.
- Results publication: PubMed 12142053Morant R, Hsu Schmitz SF, Bernhard J, Thurlimann B, Borner M, Wernli M, Egli F, Forrer P, Streit A, Jacky E, Hanselmann S, Bauer J, Hering F, Schmid HP. Vinorelbine in androgen-independent metastatic prostatic carcinoma--a phase II study. Eur J Cancer. 2002 Aug;38(12):1626-32. doi: 10.1016/s0959-8049(02)00145-4.
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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.
Rudolf Morant, MD study chair
Cantonal Hospital of St. Gallen
10 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 vinorelbine tartrate in people with Prostate Cancer, run by Swiss Cancer Institute at 10 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland. 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 NCT00003259, 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 26 Jun 2019.