Metastatic Renal Cell CarcinomaPhase 2NCT01182142
Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients
A Phase 2 study testing Capecitabine in people with Metastatic Renal Cell Carcinoma, run by Kidney Cancer Research Bureau at 1 site in Russia.
Trial summary
Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. The role of capecitabine in treatment of metastatic renal cell carcinoma is discussed. In this trial, we are evaluating efficacy of capecitabine in metastatic renal cell carcinoma patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2007to Aug 2010
- 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 confirmed non-clear cell renal cell carcinoma
- confirmed metastatic sites
- no chemotherapy in history
Who cannot join
- metastases in CNS
- previous targeted therapy
- other tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma Patients
Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. The role of capecitabine in treatment of metastatic renal cell carcinoma is discussed. In this trial, we are evaluating efficacy of capecitabine in metastatic renal cell carcinoma patients.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Capecitabine
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
1,250 mg/m2 orally twice a day, days 1-14
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Experimental | All patients will receive capecitabine. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 12 months
Secondary outcomes (1)
Overall survival Progression-free survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startSep 2007
- Primary completionSep 2009
- Study completionAug 2010
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 Metastatic Renal Cell CarcinomaStudies 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
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kidney Cancer Research Bureau
- Sponsor type
- University, hospital or other
- Investigators
- Lev Demidov, MD, D.Sc., Principal investigator, N.N. Blokhin Russian Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182142
- Sponsor's protocol ID
- CRT-06.CAP
- Status last verified
- Aug 2010
- First submitted
- 11 Aug 2010
- Last updated
- 24 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Tsimafeyeu I, Demidov L, Kharkevich G, Petenko N, Galchenko V, Sinelnikov I, Naidzionak U. Phase II, multicenter, uncontrolled trial of single-agent capecitabine in patients with non-clear cell metastatic renal cell carcinoma. Am J Clin Oncol. 2012 Jun;35(3):251-4. doi: 10.1097/COC.0b013e31820dbc17.
PubMed 21358295
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma Patients
- ClinicalTrials.gov ID
- NCT01182142
- Acronym / sponsor ID
- CRT-06.CAP
- Conditions
- Metastatic Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Kidney Cancer Research BureauUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 16 Aug 2010 (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.
Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. The role of capecitabine in treatment of metastatic renal cell carcinoma is discussed. In this trial, we are evaluating efficacy of capecitabine in metastatic renal cell carcinoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | Experimental | Drug: CapecitabineAll patients will receive capecitabine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- histologically confirmed non-clear cell renal cell carcinoma
- confirmed metastatic sites
- no chemotherapy in history
Key exclusion criteria (3 listed)
- metastases in CNS
- previous targeted therapy
- other tumor
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 |
|---|---|---|
| Capecitabine1,250 mg/m2 orally twice a day, days 1-14 | Drug | Capecitabine |
Primary outcome
Overall response rate
Time frame: 12 months
1 secondary outcome
Overall survival Progression-free survival
Time frame: 24 months
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 24 Aug 2010.
- Derived from this study: PubMed 21358295Tsimafeyeu I, Demidov L, Kharkevich G, Petenko N, Galchenko V, Sinelnikov I, Naidzionak U. Phase II, multicenter, uncontrolled trial of single-agent capecitabine in patients with non-clear cell metastatic renal cell carcinoma. Am J Clin Oncol. 2012 Jun;35(3):251-4. doi: 10.1097/COC.0b013e31820dbc17.
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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.
Lev Demidov, MD, D.Sc. principal investigator
N.N. Blokhin Russian Cancer Research 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 Capecitabine in people with Metastatic Renal Cell Carcinoma, 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 3 inclusion and 3 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 24 Aug 2010. 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?
Overall response rate (time frame: 12 months). 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 NCT01182142, 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 24 Aug 2010.