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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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00089102
Enrollment
9
Registered
2004-08-05
Start date
2003-09-30
Completion date
2009-07-31
Last updated
2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

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

DRUGgemcitabine 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

DRUGirinotecan 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

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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

MeasureTime frame
Response ProportionFrom registration until time of complete response or partial response

Secondary

MeasureTime frame
Duration of ResponseFrom registration until disease progression among patients who had at least a partial response
Number of Participants Who Experienced SAEs on StudyFrom the day of first dose until the end of study, for an average of 6 months
Progression-free SurvivalTime between registration and disease progression or death, whichever comes first.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total9

Baseline characteristics

CharacteristicGemcitabine + 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 typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
4 / 9

Outcome results

Primary

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Gemcitabine + IrinotecanResponse ProportionComplete response1 Participants
Gemcitabine + IrinotecanResponse ProportionPartial Response4 Participants
Gemcitabine + IrinotecanResponse ProportionStable or Progressive Disease2 Participants
Secondary

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.

Secondary

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Gemcitabine + IrinotecanNumber of Participants Who Experienced SAEs on StudyNumber of patients who experienced an SAE4 Participants
Gemcitabine + IrinotecanNumber of Participants Who Experienced SAEs on StudyNumber of patients who did not experience an SAE5 Participants
Secondary

Progression-free Survival

Time frame: Time between registration and disease progression or death, whichever comes first.

Population: Data for this endpoint was not collected

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026