Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer (NCT00003928) | Clinical Trial Compass
CompletedPhase 2
Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer
United States32 participantsStarted 1999-01
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well gemcitabine and cisplatin work in treating patients with metastatic kidney cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically proven metastatic renal cell carcinoma
* No brain metastases
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* WBC at least 3,500/mm\^3
* Hematocrit at least 30%
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* AST and ALT no greater than 1.5 times upper limit of normal
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No uncontrolled hypertension
* No myocardial infarction within the past 8 weeks
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other prior malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of cervix, prostate intraepithelial neoplasia, or superficial bladder cancer
* No significant psychiatric disease
* No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No more than 2 prior biologic response modifier regimens
* No concurrent biologic therapy
Chemotherapy:
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Prior radiotherapy allowed if measurable disease is outside radiation port
* At least 28 days since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* Prior surgery allowed
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin.
Timeframe: Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.