Clinical trial · Interventional
Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer
Phase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with locally advanced unresectable or 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 (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine + Irinotecan
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: irinotecan hydrochloride
Primary outcomes (1)
- measure
- Response Proportion
- timeFrame
- From registration until time of complete response or partial response
Secondary outcomes (3)
- measure
- Duration of Response
- timeFrame
- From registration until disease progression among patients who had at least a partial response
- measure
- Number of Participants Who Experienced SAEs on Study
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed renal cell carcinoma
* Locally advanced unresectable or metastatic disease
* Unidimensionally measurable disease by physical exam or imaging study
* The following are not considered measurable disease:
* Bone only disease
* Pleural or peritoneal effusions
* CNS lesions
* Irradiated lesions unless disease progression was documented after radiotherapy
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* ALT and AST \< 3 times upper limit of normal
* Bilirubin ≤ 2.0 mg/dL
Renal
* Creatinine ≤ 2.0 mg/dL
Gastrointestinal
* No active inflammatory bowel disease
* No significant bowel obstruction
* No chronic diarrhea
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study participation
* No mental incapacitation or psychiatric illness that would preclude giving informed consent
* No other active malignancy except nonmelanoma skin cancer
* No other severe disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 4 weeks since prior immunotherapy
* No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent hormones except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No concurrent palliative radiotherapy
Surgery
* Not specified
Other
* No concurrent participation in another clinical trialReferences
Publications (0)
Data not yet available