Kidney CancerPhase 2NCT00003584
Combination Chemotherapy With or Without Prednisone in Treating Patients With Recurrent and/or Metastatic Kidney Cancer
A Phase 2 study testing estramustine phosphate sodium, prednisone and vinorelbine tartrate in people with Kidney Cancer, run by University of New Mexico at 1 site 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. Combining more than one drug may kill more tumor cells. Prednisone may help to relieve symptoms in patients with recurrent and/or metastatic kidney cancer. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- estramustine phosphate sodium, prednisone and vinorelbine tartrate
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1998to Dec 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 Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven metastatic and/or recurrent renal cell carcinoma Bidimensionally measurable disease required (outside any prior radiation fields) No untreated brain metastases
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No other serious illness No serious active infection requiring therapy HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior vinca alkaloid No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy No concurrent corticosteroids (topical or inhaled corticosteroids allowed) Radiotherapy: At least 4 weeks since prior radiotherapy Less than 25% of bone marrow irradiated No concurrent radiotherapy Surgery: At least 3 weeks since prior surgery Other: No other concurrent investigational drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, 87131
About this study
Official title: A Phase II Trial of Combination Vinorelbine-Estramustine With or Without Prednisone for High Risk and Recurrent, Advanced and Metastatic Renal Cell Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Prednisone may help to relieve symptoms in patients with recurrent and/or metastatic kidney cancer.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of vinorelbine and estramustine with or without prednisone in treating patients who have recurrent and/or metastatic kidney cancer.
Read the detailed description
OBJECTIVES: I. Estimate the response rate of vinorelbine and estramustine in patients with metastatic and/or recurrent renal cell carcinoma. II. Obtain pilot data exploring the value of anti-inflammatory treatment in the management of severe systemic symptoms and improvement of treatment tolerance in this patient population.
OUTLINE: Patients are stratified according to number of risk factors (0,1 versus 2 versus 3). Patients receive vinorelbine IV on days 1, 8, 15, 22, 28, and 35. Patients also receive estramustine orally twice per day on days 1-7 and an increased dose on days 8-42. A tapered dose of oral prednisone is given to patients with an elevated erythrocyte sedimentation rate. A course of treatment consists of 6 weeks of treatment followed by 2 weeks of rest. Patients with stable disease may receive up to 4 courses of treatment. Patients who achieve a partial response may undergo surgical resection followed by up to 2 additional courses of treatment or an interleukin-2 treatment regimen. Patients with a complete response receive 1 additional course of treatment. Patients are followed until death.
PROJECTED ACCRUAL: A maximum of 35 patients will be accrued for this study.
- Conditions
- Kidney Cancer
- Being tested
- estramustine phosphate sodium, prednisone, vinorelbine tartrate
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estramustine phosphate sodiumDrug
prednisoneDrug
vinorelbine tartrateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2004 (estimated)
- Study startJul 1998
- Primary completionDec 2000
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence Elias, MD, Study chair, University of New Mexico Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003584
- Sponsor's protocol ID
- UNM-1598C
- Other IDs
- CDR0000066653, NCI-V98-1477
- Status last verified
- May 2016
- First submitted
- 1 Nov 1999
- Last updated
- 12 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Combination Vinorelbine-Estramustine With or Without Prednisone for High Risk and Recurrent, Advanced and Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00003584
- Acronym / sponsor ID
- UNM-1598C
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Jul 1998
- Primary completion
- Dec 2000 (actual)
- Study completion
- Dec 2000 (actual)
- First posted
- 9 Jun 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. Combining more than one drug may kill more tumor cells. Prednisone may help to relieve symptoms in patients with recurrent and/or metastatic kidney cancer.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of vinorelbine and estramustine with or without prednisone in treating patients who have recurrent and/or metastatic kidney cancer.
Detailed description
OBJECTIVES: I. Estimate the response rate of vinorelbine and estramustine in patients with metastatic and/or recurrent renal cell carcinoma. II. Obtain pilot data exploring the value of anti-inflammatory treatment in the management of severe systemic symptoms and improvement of treatment tolerance in this patient population.
OUTLINE: Patients are stratified according to number of risk factors (0,1 versus 2 versus 3). Patients receive vinorelbine IV on days 1, 8, 15, 22, 28, and 35. Patients also receive estramustine orally twice per day on days 1-7 and an increased dose on days 8-42. A tapered dose of oral prednisone is given to patients with an elevated erythrocyte sedimentation rate. A course of treatment consists of 6 weeks of treatment followed by 2 weeks of rest. Patients with stable disease may receive up to 4 courses of treatment. Patients who achieve a partial response may undergo surgical resection followed by up to 2 additional courses of treatment or an interleukin-2 treatment regimen. Patients with a complete response receive 1 additional course of treatment. Patients are followed until death.
PROJECTED ACCRUAL: A maximum of 35 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- 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 |
|---|---|---|
| estramustine phosphate sodium | Drug | – |
| prednisone | Drug | – |
| 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 12 May 2016.
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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.
Laurence Elias, MD study chair
University of New Mexico Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing estramustine phosphate sodium, prednisone and vinorelbine tartrate in people with Kidney Cancer, run by University of New Mexico at 1 site in United States.
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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 12 May 2016.