Kidney Cancer
Conditions
Keywords
recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer
Brief summary
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.
Detailed description
OBJECTIVES: Primary * Determine response in patients with locally advanced unresectable or metastatic renal cell carcinoma treated with gemcitabine and irinotecan. Secondary * Determine the duration of response in patients treated with this regimen. * Determine the tolerance to and toxicity of this regimen in these patients. * Determine median and progression-free survival in patients treated with this regimen. OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond best response. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study within 30 months.
Interventions
1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle
100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle
Sponsors
Study design
Eligibility
Inclusion criteria
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 trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Proportion | From registration until time of complete response or partial response |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response | From registration until disease progression among patients who had at least a partial response |
| Number of Participants Who Experienced SAEs on Study | From the day of first dose until the end of study, for an average of 6 months |
| Progression-free Survival | Time between registration and disease progression or death, whichever comes first. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine + Irinotecan gemcitabine hydrochloride: 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle
irinotecan hydrochloride: 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Gemcitabine + Irinotecan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 4 / 9 |
Outcome results
Response Proportion
Time frame: From registration until time of complete response or partial response
Population: All patients treated on study who underwent a response assessment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gemcitabine + Irinotecan | Response Proportion | Complete response | 1 Participants |
| Gemcitabine + Irinotecan | Response Proportion | Partial Response | 4 Participants |
| Gemcitabine + Irinotecan | Response Proportion | Stable or Progressive Disease | 2 Participants |
Duration of Response
Time frame: From registration until disease progression among patients who had at least a partial response
Population: Data is not available for this endpoint was not collected.
Number of Participants Who Experienced SAEs on Study
Time frame: From the day of first dose until the end of study, for an average of 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gemcitabine + Irinotecan | Number of Participants Who Experienced SAEs on Study | Number of patients who experienced an SAE | 4 Participants |
| Gemcitabine + Irinotecan | Number of Participants Who Experienced SAEs on Study | Number of patients who did not experience an SAE | 5 Participants |
Progression-free Survival
Time frame: Time between registration and disease progression or death, whichever comes first.
Population: Data for this endpoint was not collected