Clinical trial · Interventional
Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer
Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Overall response
- measure
- Safety and efficacy
Secondary outcomes (1)
- measure
- Difference in response to therapy in patients with clear vs nonclear cell renal cell carcinoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available