Suspended

Phase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma

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What is being tested

gemcitabine hydrochloride

+ irinotecan hydrochloride
Drug
Who is being recruted

Urogenital Diseases
+13

+ Adenocarcinoma
+ Carcinoma
From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorMedical University of South Carolina
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitlePhase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma 
NCT00089102
Principal SponsorMedical University of South Carolina
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
9 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Adenocarcinoma
Carcinoma
Carcinoma, Renal Cell
Female Urogenital Diseases and Pregnancy Complications
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Female Urogenital Diseases
Male Urogenital Diseases
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental

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
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Hollings Cancer Center at Medical University of South CarolinaCharleston, United StatesSee the location
Suspended
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, United States
Suspended2 Study Centers
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