Carcinoma, Renal CellPhase 2NCT00591188
Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens
A Phase 2 study testing capecitabine, interferon-alpha in people with Carcinoma, Renal Cell, run by Kidney Cancer Research Bureau at 1 site in Russia.
Trial summary
The aim of this study is to determine preliminary efficacy of capecitabine and interferon-alpha in second-line after interleukin-2 based regimens in patients with MRCC Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- capecitabine, interferon-alpha
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2006to May 2008
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed renal carcinoma
- CT-confirmed metastatic sites
- Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion measured as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan
- Disease progression after IL-2
- Age 18 or older
- ECOG performance status 1-3
Show all 22Show fewer
- Life expectancy ≥ 2 months
- WBC ≥ 3,000/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 7.5 g/dL
- Creatinine ≤ 1.5 mg/dL (2.0 mg/dL in post-nephrectomy patients)
- Total bilirubin ≤ 1.5 mg/dL
- AST ≤ 3.0 times normal
- Alkaline phosphatase ≤ 2.5 times normal (10 times ULN in presence of bone metastases)
- Not pregnant or nursing
- No history of autoimmune
- No history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)
- No CNS metastases by neurologic exam and/or MRI
- No history of seizure disorders
- No local and/or systemic infections requiring antibiotics within 28 days prior to study entry
- No other malignancy
- Written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens
The aim of this study is to determine preliminary efficacy of capecitabine and interferon-alpha in second-line after interleukin-2 based regimens in patients with MRCC
- Conditions
- Carcinoma, Renal Cell
- Being tested
- capecitabine, interferon-alpha
- Keywords
- kidney cancer, capecitabine, interferon
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine, interferon-alphaDrug
Patients who meet inclusion/exclusion criteria will receive combination of study drugs.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All patients will receive capecitabine and interferon-alpha. Receives: Drug: capecitabine, interferon-alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate progression-free survival with capecitabine and interferon treatment in metastatic renal cell carcinoma (MRCC) patients (pts) with IL-2 failure in first-line
Measured: one year
Secondary outcomes (2)
Evaluate the safety and tolerability of the capecitabine and interferon combination
Measured: one year
Evaluate response rate and overall survival with the capecitabine and interferon combination in MRCC pts with progression on IL-2 based regimens
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startDec 2006
- Primary completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kidney Cancer Research Bureau
- Sponsor type
- University, hospital or other
- Investigators
- Ilya V. Tsimafeyeu, MD, Principal investigator, Kidney Cancer Research BureauLev V. Demidov, MD, DSc., Study director, N.N. Blokhin Russian Cancer Research Bureau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591188
- Sponsor's protocol ID
- CRT-003
- Other IDs
- CRT-003
- Status last verified
- Apr 2009
- First submitted
- 28 Dec 2007
- Last updated
- 1 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens
- ClinicalTrials.gov ID
- NCT00591188
- Acronym / sponsor ID
- CRT-003
- Conditions
- Carcinoma, Renal Cell
- Keywords
- kidney cancer, capecitabine, interferon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Kidney Cancer Research BureauUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- May 2008 (actual)
- First posted
- 11 Jan 2008 (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.
The aim of this study is to determine preliminary efficacy of capecitabine and interferon-alpha in second-line after interleukin-2 based regimens in patients with MRCC
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: capecitabine, interferon-alphaAll patients will receive capecitabine and interferon-alpha. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically or cytologically confirmed renal carcinoma
- CT-confirmed metastatic sites
- Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion measured as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan
- Disease progression after IL-2
- Age 18 or older
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| capecitabine, interferon-alphaPatients who meet inclusion/exclusion criteria will receive combination of study drugs. | Drug | 1 |
Primary outcome
Evaluate progression-free survival with capecitabine and interferon treatment in metastatic renal cell carcinoma (MRCC) patients (pts) with IL-2 failure in first-line
Time frame: one year
2 secondary outcomes
Evaluate the safety and tolerability of the capecitabine and interferon combination
Time frame: one year
Evaluate response rate and overall survival with the capecitabine and interferon combination in MRCC pts with progression on IL-2 based regimens
Time frame: one year
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 1 May 2009.
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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.
Ilya V. Tsimafeyeu, MD principal investigator
Kidney Cancer Research Bureau
Lev V. Demidov, MD, DSc. study director
N.N. Blokhin Russian Cancer Research Bureau
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 capecitabine, interferon-alpha in people with Carcinoma, Renal Cell, run by Kidney Cancer Research Bureau at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. 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 1 May 2009. 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 Russia. 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?
Evaluate progression-free survival with capecitabine and interferon treatment in metastatic renal cell carcinoma (MRCC) patients (pts) with IL-2 failure in first-line (time frame: one year). It is what the study was designed to measure, not a finding.
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 1 May 2009.