Kidney CancerPhase 2NCT00401128
Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer
A Phase 2 study testing gemcitabine hydrochloride and irinotecan hydrochloride in people with Kidney Cancer, run by The Cleveland Clinic at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- gemcitabine hydrochloride and irinotecan hydrochloride
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Feb 2007
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed epithelial renal cell carcinoma (RCC), including either clear cell or nonclear cell RCC
- Strong clinical evidence or biopsy proof of metastases to a site or sites distant from the primary tumor
- Measurable disease
- No untreated or progressive CNS metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy > 3 months
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Hemoglobin > 9.5 g/dL
- Creatinine ≤ 1.8 mg/dL
- Bilirubin < 1.5 mg/dL
- Calcium < 11.5 mg/dL
- ALT and AST < 3 times upper limit of normal
- No history of any of the following:
- Serious cardiac arrhythmia or cardiac arrhythmia requiring treatment
- Congestive heart failure
- Angina pectoris
- Other severe cardiovascular disease producing limitations of physical activity (i.e., New York Heart Association class III-IV heart disease)
- No other prior malignancy except for the following:
- Basal cell or squamous cell carcinoma of the skin
- Carcinoma in situ of the uterine cervix
- Any malignancy treated with curative intent and in complete remission for > 3 years
- No active peptic ulcer disease, inflammatory bowel disease, or chronic diarrhea
- No local or systemic infections requiring IV antibiotics within the past 28 days
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- Recovered from prior hormonal therapy, radiotherapy, biologic therapy, or chemotherapy
- No more than 3 prior therapeutic regimens for metastatic disease
- No prior organ allograft
- More than 28 days since prior major surgery requiring general anesthesia
- More than 28 days since prior radiotherapy to control pain from skeletal lesions
- More than 28 days since prior hormonal treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with irinotecan works in treating patients with metastatic kidney cancer.
Read the detailed description
OBJECTIVES:
- Determine the response rate in patients with epithelial (clear or nonclear cell) renal cell carcinoma (RCC) treated with gemcitabine hydrochloride and irinotecan hydrochloride.
- Compare the response in patients with clear cell RCC vs nonclear cell RCC treated with this regimen.
- Determine the toxicities of this regimen.
OUTLINE: This is an open-label study.
Patients receive gemcitabine hydrochloride IV over 30 minutes and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Conditions
- Kidney Cancer
- Being tested
- gemcitabine hydrochloride, irinotecan hydrochloride
- Keywords
- clear cell renal cell carcinoma, recurrent renal cell cancer, papillary renal cell carcinoma, stage IV 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response
Safety and efficacy
Secondary outcomes (1)
Difference in response to therapy in patients with clear vs nonclear cell renal cell carcinoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startMay 2004
- Primary completionFeb 2007
- Study completionFeb 2007
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.
- More trials run by The Cleveland ClinicThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ronald M. Bukowski, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401128
- Sponsor's protocol ID
- CASE-CCF-6695
- Other IDs
- P30CA043703, CASE-CCF-6695
- Status last verified
- Apr 2017
- First submitted
- 16 Nov 2006
- Last updated
- 20 Apr 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00401128
- Acronym / sponsor ID
- CASE-CCF-6695
- Conditions
- Kidney Cancer
- Keywords
- clear cell renal cell carcinoma, recurrent renal cell cancer, papillary renal cell carcinoma, stage IV renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2004
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 17 Nov 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.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with irinotecan works in treating patients with metastatic kidney cancer.
Detailed description
OBJECTIVES:
- Determine the response rate in patients with epithelial (clear or nonclear cell) renal cell carcinoma (RCC) treated with gemcitabine hydrochloride and irinotecan hydrochloride.
- Compare the response in patients with clear cell RCC vs nonclear cell RCC treated with this regimen.
- Determine the toxicities of this regimen.
OUTLINE: This is an open-label study.
Patients receive gemcitabine hydrochloride IV over 30 minutes and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| gemcitabine hydrochloride | Drug | – |
| irinotecan hydrochloride | Drug | – |
Primary outcome
Overall response
Safety and efficacy
1 secondary outcome
Difference in response to therapy in patients with clear vs nonclear cell renal cell carcinoma
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 20 Apr 2017.
Related trials for Kidney Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
Ronald M. Bukowski, MD study chair
The Cleveland Clinic
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 gemcitabine hydrochloride and irinotecan hydrochloride in people with Kidney Cancer, run by The Cleveland Clinic 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 20 Apr 2017. 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.
What does the primary outcome measure?
Overall response. The study lists 2 primary outcomes in all. 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 20 Apr 2017.