Kidney CancerPhase 2NCT00058318
S0312, Gemcitabine and Capecitabine in Treating Patients With Advanced Renal Cell (Kidney) Cancer
A Phase 2 study testing capecitabine and gemcitabine hydrochloride in people with Kidney Cancer, run by SWOG Cancer Research Network.
Trial summary
RATIONALE: Drugs used in chemotherapy such as gemcitabine and capecitabine use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- capecitabine and gemcitabine hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed renal cell carcinoma
- Metastatic (M1) disease OR
- M0 provided the primary tumor is unresectable
- Measurable disease
- At least 1 unidimensionally measurable lesion
- Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease
- Soft tissue disease within a prior radiation field is measurable provided it has progressed since therapy and there is also measurable disease outside of the irradiated field
- No prior or concurrent brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (SGOT) no greater than 1.5 times ULN
Renal
- Creatinine clearance at least 50 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other concurrent uncontrolled illness that would preclude study participation
- No psychiatric illness or social situation that would preclude study compliance
- No uncontrolled diabetes mellitus
- No ongoing or active infection
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No more than 2 prior immunotherapy regimens comprising interferon (IFN) and/or interleukin-2 (IL-2)
- At least 28 days since prior IFN or IL-2 and recovered
Chemotherapy
- No prior chemotherapy for renal cell cancer
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- No prior radiotherapy to 25% or more of the bone marrow
- At least 21 days since prior radiotherapy and recovered
Surgery
- At least 28 days since prior surgery and recovered
- Prior resection of the primary tumor allowed (in patients with metastatic disease)
Other
- At least 4 weeks since prior sorivudine or brivudine
- No concurrent sorivudine or chemically related analogues (e.g., brivudine)
About this study
Official title: A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer
RATIONALE: Drugs used in chemotherapy such as gemcitabine and capecitabine use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have advanced renal cell cancer (kidney cancer).
Read the detailed description
OBJECTIVES:
- Determine response (confirmed and unconfirmed complete and partial) of patients with advanced renal cell cancer treated with gemcitabine and capecitabine.
- Determine the 6-month time to treatment failure rate and overall survival rate of patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Correlate, preliminarily, tumor response with the intratumoral content of the enzymes involved in the activation and degradation of these drugs in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 3.8-4.2 months.
- Conditions
- Kidney Cancer
- Being tested
- capecitabine, gemcitabine hydrochloride
- Keywords
- stage IV renal cell cancer, stage III 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.
capecitabineDrug
Capecitabine will be given 625 mg/m^2 (1250 mg/m^2/day) by mouth twice a day on day 1-21 for every cycle (1 cycle =28 days) until disease progression
Gemcitabine will be given 900 mg/m^2 by intravenous infusion over 30 minutes on day 1, 8, and 15 for every cycle (1 cycle = 28 days) until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Gemcitabine + Capecitabine Receives: Drug: capecitabine; Drug: gemcitabine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Measured: every 8 weeks until progression
Secondary outcomes (2)
Survival
Measured: every 8 weeks while on treatment, then every 3 months for first year, then every 6 months for 3 years
Time to treatment failure
Measured: every 8 weeks until progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2003 (estimated)
- Study startDec 2004
- Primary completionMay 2007
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Peter J. VanVeldhuizen, MD, Study chair, Kansas City Veteran Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058318
- Sponsor's protocol ID
- CDR0000288820
- Other IDs
- U10CA032102, S0312
- Status last verified
- Oct 2012
- First submitted
- 7 Apr 2003
- Last updated
- 2 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Van Veldhuizen PJ, Hussey M, Lara PN Jr, Mack PC, Gandour-Edwards R, Clark JI, Lange MK, Crawford DE. A phase ii study of gemcitabine and capecitabine in patients with advanced renal cell cancer: Southwest Oncology Group Study S0312. Am J Clin Oncol. 2009 Oct;32(5):453-9. doi: 10.1097/COC.0b013e3181925176.
PubMed 19487915van Veldhuizen PJ, Hussey M, Lara PN, et al.: A phase II study of IV gemcitabine (G) and oral capecitabine (C) in patients (pts) with advanced renal cell cancer (RCC): results of Southwest Oncology Group study 0312. [Abstract] J Clin Oncol 25 (Suppl 18): A-15562, 654s, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients With Advanced Renal Cell Cancer
- ClinicalTrials.gov ID
- NCT00058318
- Acronym / sponsor ID
- CDR0000288820
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer, stage III renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2004
- Primary completion
- May 2007 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 9 Apr 2003 (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 such as gemcitabine and capecitabine use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have advanced renal cell cancer (kidney cancer).
Detailed description
OBJECTIVES:
- Determine response (confirmed and unconfirmed complete and partial) of patients with advanced renal cell cancer treated with gemcitabine and capecitabine.
- Determine the 6-month time to treatment failure rate and overall survival rate of patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Correlate, preliminarily, tumor response with the intratumoral content of the enzymes involved in the activation and degradation of these drugs in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 3.8-4.2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: capecitabine, Drug: gemcitabine hydrochlorideGemcitabine + Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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 |
|---|---|---|
| capecitabineCapecitabine will be given 625 mg/m^2 (1250 mg/m^2/day) by mouth twice a day on day 1-21 for every cycle (1 cycle =28 days) until disease progression | Drug | Treatment |
| gemcitabine hydrochlorideGemcitabine will be given 900 mg/m^2 by intravenous infusion over 30 minutes on day 1, 8, and 15 for every cycle (1 cycle = 28 days) until disease progression. | Drug | Treatment |
Primary outcome
Response
Time frame: every 8 weeks until progression
2 secondary outcomes
Survival
Time frame: every 8 weeks while on treatment, then every 3 months for first year, then every 6 months for 3 years
Time to treatment failure
Time frame: every 8 weeks until progression
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 2 Nov 2012.
- Results publication: PubMed 19487915Van Veldhuizen PJ, Hussey M, Lara PN Jr, Mack PC, Gandour-Edwards R, Clark JI, Lange MK, Crawford DE. A phase ii study of gemcitabine and capecitabine in patients with advanced renal cell cancer: Southwest Oncology Group Study S0312. Am J Clin Oncol. 2009 Oct;32(5):453-9. doi: 10.1097/COC.0b013e3181925176.
- Results publicationvan Veldhuizen PJ, Hussey M, Lara PN, et al.: A phase II study of IV gemcitabine (G) and oral capecitabine (C) in patients (pts) with advanced renal cell cancer (RCC): results of Southwest Oncology Group study 0312. [Abstract] J Clin Oncol 25 (Suppl 18): A-15562, 654s, 2007.
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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.
Peter J. VanVeldhuizen, MD study chair
Kansas City Veteran Affairs Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine and gemcitabine hydrochloride in people with Kidney Cancer, run by SWOG Cancer Research Network.
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 2 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Response (time frame: every 8 weeks until progression). 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 NCT00058318, which also lists 2 linked publications.
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 2 Nov 2012.