Renal Cell CancerPhase 3NCT00311467
Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma
A Phase 3 study testing Capecitabine, Interferon, Interleukin in people with Renal Cell Cancer, run by Central European Cooperative Oncology Group at 1 site in Austria.
Trial summary
Multi-center, prospective randomised phase III study evaluating capecitabine in combination with standard-immunotherapy versus standard-immunotherapy alone as first-line therapy in patients with metastatic renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Renal Cell Cancer
- What is being tested?
- Capecitabine, Interferon, Interleukin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2004to May 2007
- Phase
- Phase 3
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed renal cell carcinoma (primary tumour or biopsy/surgery of metastases)
- Radiologically confirmed metastatic disease
- Surgically removed primary tumour so feasible (nephrectomy or nephron-sparing surgery as indicated)
- Karnofsky-Performance Status >70%
- Age 19-75 years
- Life expectancy of at least 3 months
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- Adequate bone marrow function (i.e. white blood cell count above 3000/μL, platelet count above 75 000 /μL, hemoglobin above 9 mg/dl)
- Adequate organ function (i.e. serum creatinine, bilirubin and AST below 1.25 x the upper limit of the institutions' normal range)
- Negative pregnancy test for female patients
- Written informed consent
Who cannot join
- Age <19 or >75 years
- Karnofsky-Performance Status < 70%
- Untreated or uncontrolled brain metastases
- Second neoplasia
- Primary tumour surgically removable
- Solitary, surgically removable metastases
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- Major concomitant diseases of the cardiovascular, respiratory or renal systems, as well as active systemic infections
- Severe renal disease or liver insufficiency or myeloid dysfunction (including patients with a history of a disease that is likely to interfere with the metabolism or excretion of the test medication)
- Other less common diseases as peptic ulcer disease, inflammatory bowel disease, autoimmune disease (severe known psoriasis, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis etc.)
- Drug addiction (including excessive alcohol consumption) within 1 year prior to study start.
- History of other conditions consistent with decompensated liver disease or other evidence of bleeding form esophageal varices.
- History of chronic hepatitis and immunsupressiva
- Known HIV Infection
- Evidence of allergy or hypersensitivity against recombinant Interferon alfa-2a or other components of preparation.
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease.
- Seizure disorders and /or compromised central nervous system function.
- History of evidence of severe retinopathy
- Patient unwilling or unable to give informed consent
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma: a Prospective, Randomized, Multi-center phaseIII-Trial
Multi-center, prospective randomised phase III study evaluating capecitabine in combination with standard-immunotherapy versus standard-immunotherapy alone as first-line therapy in patients with metastatic renal cell carcinoma.
Read the detailed description
Treatment plan Group A
Patients randomised to group A will receive treatment according to the following treatment schedule:
Group A: Combined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy
- Week 1:Capecitabine / Interferon;
- Week 2:Capecitabine / Interferon;
- Week 3:REST PERIOD / Interleukin;
- Week 4:Capecitabine / Interleukin;
- Week 5:Capecitabine / REST PERIOD;
- Week 6:REST PERIOD / Interferon;
- Week 7:Capecitabine / Interferon;
- Week 8:Capecitabine / Interleukin;
- Week 9:REST PERIOD / Interleukin;
- Week 10:Capecitabine / REST PERIOD;
- Week 11:Capecitabine / Interferon;
- Week 12:REST PERIOD / Interferon;
- Week 13:Capecitabine / Interleukin;
- Week 14:Capecitabine / Interleukin;
DOSAGES AND ROUTES OF ADMINISTRATION:
Capecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days.
Interferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d.
Interleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day.
Group B
Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine.
Efficacy evaluations will be performed every 14 weeks of treatment in both groups
- Conditions
- Renal Cell Cancer
- Being tested
- Capecitabine, Interferon, Interleukin
- Keywords
- renal cell cancer
- 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.
Capecitabine, Interferon, InterleukinDrug
Capecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days.
Interferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d.
Interleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day.
Group B
Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine.
Efficacy evaluations will be performed every 14 weeks of treatment in both groups
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine and Interferon | Active comparator | Combined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy Receives: Drug: Capecitabine, Interferon, Interleukin |
| Interferon | Active comparator | Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine.
Efficacy evaluations will be performed every 14 weeks of treatment in both groups Receives: Drug: Capecitabine, Interferon, Interleukin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study objective is to investigate whether the addition of capecitabine to interferon-alpha-interleukin-2 based immunotherapy may improve progression free survival when compared to immunotherapy alone.
Secondary outcomes (1)
The study's secondary objectives are to investigate differences in response rates, safety and survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startMar 2004
- Primary completionMay 2007
- Study completionMay 2007
Why it stopped: no patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central European Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuela Schmidinger, Prof, Principal investigator, Univ. Klinik f. Innere Med. I, Abt. Onkologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311467
- Sponsor's protocol ID
- CECOG RCC 1.3.001
- Status last verified
- May 2012
- First submitted
- 5 Apr 2006
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma: a Prospective, Randomized, Multi-center phaseIII-Trial
- ClinicalTrials.gov ID
- NCT00311467
- Acronym / sponsor ID
- CECOG RCC 1.3.001
- Conditions
- Renal Cell Cancer
- Keywords
- renal cell cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no patient recruitment
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Central European Cooperative Oncology GroupUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 6 Apr 2006 (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.
Multi-center, prospective randomised phase III study evaluating capecitabine in combination with standard-immunotherapy versus standard-immunotherapy alone as first-line therapy in patients with metastatic renal cell carcinoma.
Detailed description
Treatment plan Group A
Patients randomised to group A will receive treatment according to the following treatment schedule:
Group A: Combined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy
- Week 1:Capecitabine / Interferon;
- Week 2:Capecitabine / Interferon;
- Week 3:REST PERIOD / Interleukin;
- Week 4:Capecitabine / Interleukin;
- Week 5:Capecitabine / REST PERIOD;
- Week 6:REST PERIOD / Interferon;
- Week 7:Capecitabine / Interferon;
- Week 8:Capecitabine / Interleukin;
- Week 9:REST PERIOD / Interleukin;
- Week 10:Capecitabine / REST PERIOD;
- Week 11:Capecitabine / Interferon;
- Week 12:REST PERIOD / Interferon;
- Week 13:Capecitabine / Interleukin;
- Week 14:Capecitabine / Interleukin;
DOSAGES AND ROUTES OF ADMINISTRATION:
Capecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days.
Interferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d.
Interleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day.
Group B
Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine.
Efficacy evaluations will be performed every 14 weeks of treatment in both groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine and Interferon | Active comparator | Drug: Capecitabine, Interferon, InterleukinCombined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy |
| Interferon | Active comparator | Drug: Capecitabine, Interferon, InterleukinPatients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine. Efficacy evaluations will be performed every 14 weeks of treatment in both groups |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed renal cell carcinoma (primary tumour or biopsy/surgery of metastases)
- Radiologically confirmed metastatic disease
- Surgically removed primary tumour so feasible (nephrectomy or nephron-sparing surgery as indicated)
- Karnofsky-Performance Status >70%
- Age 19-75 years
Key exclusion criteria (19 listed)
- Age <19 or >75 years
- Karnofsky-Performance Status < 70%
- Untreated or uncontrolled brain metastases
- Second neoplasia
- Primary tumour surgically removable
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, InterleukinCapecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days. Interferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d. Interleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day. Group B Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine. Efficacy evaluations will be performed every 14 weeks of treatment in both groups | Drug | Capecitabine and Interferon, Interferon |
Primary outcome
The primary study objective is to investigate whether the addition of capecitabine to interferon-alpha-interleukin-2 based immunotherapy may improve progression free survival when compared to immunotherapy alone.
1 secondary outcome
The study's secondary objectives are to investigate differences in response rates, safety and survival.
Results and safety
The study was stopped early (reason given: no patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
- Related InfoLink provided by the sponsor.
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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.
Manuela Schmidinger, Prof principal investigator
Univ. Klinik f. Innere Med. I, Abt. Onkologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capecitabine, Interferon, Interleukin in people with Renal Cell Cancer, run by Central European Cooperative Oncology Group at 1 site in Austria.
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 10 inclusion and 19 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: stopped early, as of the sponsor's last update on 16 May 2012. 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 Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: no patient recruitment). Results are not available in the source record.
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?
The primary study objective is to investigate whether the addition of capecitabine to interferon-alpha-interleukin-2 based immunotherapy may improve progression free survival when compared to immunotherapy alone.. 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 16 May 2012.