Bladder CancerPhase 3NCT00237575
Randomized Phase III Trial of Leukine® vs Neupogen® in Patients Receiving Cisplatin & Gemcitabine for Urothelial Cancer
A Phase 3 study testing gemcitabine, cisplatin and sargramostim in people with Bladder Cancer, run by University of Kentucky at 4 sites in United States.
Trial summary
The main objective of this study is to compare the effectiveness of Leukine \& Neupogen to decrease the incidence of grade 3 \& 4 neutropenia in the treatment of patients receiving cisplatin \& gemcitabine for urothelial (bladder) cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- gemcitabine, cisplatin and sargramostim
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2005to Mar 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven, regionally advanced (T4b, N2, N3), or metastatic (M1) urothelial cancer of the bladder, ureter, or renal pelvis
- A minimum of one target lesion according to the RECIST criteria (Appendix D). Note: Bone metastases, leptomeningeal disease, ascites, pleural or pericardial effusions, lymphangitic spread or cystic lesions are not acceptable as target lesions.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Appendix B).
- Age >/=18 years or the age of majority in the state of the participating institution.
- Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter. Post menopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
- An expected survival of at least four months.
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- Adequate organ and marrow function as defined as follows:
- leukocytes >/=3,000/µl,
- absolute neutrophil count >/=1,500/µl,
- hemoglobin >/=8.0g/dl,
- platelets >/=100,000/µl,
- total bilirubin and serum creatinine must be < 1.5 mg/dl
- liver transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional ULN if alkaline phosphatase is </=ULN, or
- alkaline phosphatase may be up to 4 x ULN if transaminases are </=ULN.
- Patients who have undergone previous radiation therapy or surgery may be enrolled into the study but such treatment must have been completed 4 or more weeks prior to entry to the study and the patient must have recovered. Further, patients who have undergone radiotherapy may not have received radiation to > 25% of the bone marrow. Previous intravesicular immunotherapy and chemotherapy are allowed.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Undergone previous systemic chemotherapy.
- Major surgery <4 weeks prior to study treatment start, or lack of complete recovery from major surgery.
- Participation in any investigational drug study within 4 weeks preceding treatment start.
- History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be significant enough to preclude informed consent or interfering with compliance for oral drug intake.
- Previous history of cancer unless treatment was curative and completed >/=5 years prior to entry onto study, or unless diagnosed as one of the following: in situ carcinoma (any location), basal cell carcinoma, or non-metastatic squamous cell carcinoma of the skin.
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled or untreated cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because of the teratogenic potential of cisplatin and gemcitabine. Lactating women are also excluded. (Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.)
- Peripheral neuropathy >/= grade 2.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
New York Medical College
Hawthorne, New York, 10532
University of Louisville
Louisville, Kentucky, 40202
University of Nebraska
Omaha, Nebraska, 68198-7680
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Randomized Phase III Trial of Leukine® vs Neupogen® in Patients Receiving Cisplatin and Gemcitabine for Regionally Advanced or Metastatic Urothelial Cancer
The main objective of this study is to compare the effectiveness of Leukine \& Neupogen to decrease the incidence of grade 3 \& 4 neutropenia in the treatment of patients receiving cisplatin \& gemcitabine for urothelial (bladder) cancer.
All patients will receive chemotherapy with cisplatin plus gemcitabine in six 21-day cycles. Patients will also receive either Leukine (Arm A) or Neupogen (Arm B).
Read more
Patient Population: 100 patients will be enrolled (n=100) in this study. Patients cannot have undergone previous chemotherapy. Approximately 50 patients will be enrolled into each treatment arm.
Test Product, Dose, Mode of Administration: All patients will receive chemotherapy treatment with cisplatin (70 mg/kg) on Day 1 and gemcitabine (1000 mg/m2) on Days 1, 8, \& 15 of each 21-day cycle. Patients will be randomized to receive either Leukine (250 µg/m2) or Neupogen (5 µg/kg) injected under the skin on Days 2-6, 9-13, \& 16-20 of each cycle.
Duration of Treatment: Patients will receive a maximum of six 21-day cycles of treatment. The overall trial, including follow-up, is expected to be 3 years in duration.
Read the detailed description
Objectives: To compare the efficacy of Leukine and Neupogen in the treatment of patients receiving cisplatin and gemcitabine for regionally advanced or metastatic urothelial cancer in regard to reduction of grade 3 and 4 neutropenia. Secondary objectives include a comparison of: hematologic and non-hematologic toxicities, anti-tumor effects, dose intensity, and quality of life in each treatment arm.
Methodology: The study will be a multi-institutional, randomized, phase III study in patients with regionally advanced or metastatic urothelial cancer. All patients will receive chemotherapy with cisplatin plus gemcitabine for six 21-day cycles. Patients will receive hematopoietic growth factor support with either Leukine (Arm A), or Neupogen (Arm B). Rates of anti-tumor responses and the incidence of toxicities in each treatment arm will provide a comparison of efficacy and safety for the hematopoietic support regimens.
Patient Population: Patients to be enrolled (n=100) in this study will have received a diagnosis of regionally advanced or metastatic urothelial cancer of the bladder, ureter, or renal pelvis and will have not undergone previous systemic chemotherapy. Approximately 50 patients will be enrolled into each treatment arm.
Main Criteria for Inclusion: Inclusion criteria for this study specify that patients have evaluable, biopsy-proven, surgically unresectable, regionally advanced, or metastatic urothelial cancer of the bladder, ureter, or renal pelvis. Additionally, patients must have an Eastern Cooperative Oncology Group performance status of 0-2 and adequate bone marrow, renal, and hepatic function. Patients who have undergone previous systemic chemotherapy will be excluded from this study.
Test Product, Dose, Mode of Administration: All patients will receive chemotherapeutic treatment with cisplatin (70 mg/kg) intravenously on Day 1 and gemcitabine (1000 mg/m2) intravenously on Days 1, 8, and 15 of each 21-day cycle. Patients will be randomized to receive either Leukine (250 µg/m2) or Neupogen (5 µg/kg) subcutaneously on Days 2-6, 9-13, and 16-20 of each cycle.
Duration of Treatment: Patients will receive a maximum of six 21-day cycles of treatment. The overall trial, including follow-up, is expected to be 3 years in duration.
Criteria for Evaluation: Efficacy will be assessed by, incidence of grade 3 and 4 toxicities, evaluation of complete and partial response, time to progression, overall and disease specific survival, planned vs administered doses, and quality of life. Safety will be assessed by, vital signs, physical examinations, clinical laboratory evaluations, and the reporting of adverse events.
- Conditions
- Bladder Cancer
- Being tested
- gemcitabine, cisplatin, sargramostim, filgrastim
- Keywords
- urothelial, bladder, gemcitabine, cisplatin, leukine, neupogen, filgrastim, sargramostim, metastatic, Regionally Advanced, Advanced
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabineDrug
cisplatinDrug
sargramostimDrug
filgrastimDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Leukine & Neupogen to prevent grade 3 & 4 neutropenia in patients receiving cisplatin & gemcitabine: assessed before cycles 3 & 5, then at end of treatment.
Safety of Leukine & Neupogen: evaluated before each cycle & blood work is evaluated weekly throughout the study.
Secondary outcomes (6)
Reduction of grade 3 & 4 hematologic toxicities: evaluated weekly throughout the study.
Reduction of clinical hematologic toxicity including the # of: hospital days required for febrile neutropenia, transfusions & bleeding events, & days of outpatient antibiotics: evaluated throughout the study treatment and until resolved.
Reduction of non-hematologic toxicities: evaluated prior to each cycle.
Enhancement of anti-tumor effects (CR & PR, time to progression, OS & DFS): assessed before cycles 3 & 5, then on day 22 of cycle 6.
Dose intensity as planned vs administered: assessed during each treatment.
Quality of life: evaluated at baseline, pre-cylces 3 & 5, & end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- John Rinehart, MD, Study chair, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237575
- Sponsor's protocol ID
- 04-GU-53B
- Status last verified
- May 2012
- First submitted
- 10 Oct 2005
- Last updated
- 23 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial of Leukine® vs Neupogen® in Patients Receiving Cisplatin and Gemcitabine for Regionally Advanced or Metastatic Urothelial Cancer
- ClinicalTrials.gov ID
- NCT00237575
- Acronym / sponsor ID
- 04-GU-53B
- Conditions
- Bladder Cancer
- Keywords
- urothelial, bladder, gemcitabine, cisplatin, leukine, neupogen, filgrastim, sargramostim
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 100 participants
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Nov 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to compare the effectiveness of Leukine \& Neupogen to decrease the incidence of grade 3 \& 4 neutropenia in the treatment of patients receiving cisplatin \& gemcitabine for urothelial (bladder) cancer.
All patients will receive chemotherapy with cisplatin plus gemcitabine in six 21-day cycles. Patients will also receive either Leukine (Arm A) or Neupogen (Arm B).
Patient Population: 100 patients will be enrolled (n=100) in this study. Patients cannot have undergone previous chemotherapy. Approximately 50 patients will be enrolled into each treatment arm.
Test Product, Dose, Mode of Administration: All patients will receive chemotherapy treatment with cisplatin (70 mg/kg) on Day 1 and gemcitabine (1000 mg/m2) on Days 1, 8, \& 15 of each 21-day cycle. Patients will be randomized to receive either Leukine (250 µg/m2) or Neupogen (5 µg/kg) injected under the skin on Days 2-6, 9-13, \& 16-20 of each cycle.
Duration of Treatment: Patients will receive a maximum of six 21-day cycles of treatment. The overall trial, including follow-up, is expected to be 3 years in duration.
Detailed description
Objectives: To compare the efficacy of Leukine and Neupogen in the treatment of patients receiving cisplatin and gemcitabine for regionally advanced or metastatic urothelial cancer in regard to reduction of grade 3 and 4 neutropenia. Secondary objectives include a comparison of: hematologic and non-hematologic toxicities, anti-tumor effects, dose intensity, and quality of life in each treatment arm.
Methodology: The study will be a multi-institutional, randomized, phase III study in patients with regionally advanced or metastatic urothelial cancer. All patients will receive chemotherapy with cisplatin plus gemcitabine for six 21-day cycles. Patients will receive hematopoietic growth factor support with either Leukine (Arm A), or Neupogen (Arm B). Rates of anti-tumor responses and the incidence of toxicities in each treatment arm will provide a comparison of efficacy and safety for the hematopoietic support regimens.
Patient Population: Patients to be enrolled (n=100) in this study will have received a diagnosis of regionally advanced or metastatic urothelial cancer of the bladder, ureter, or renal pelvis and will have not undergone previous systemic chemotherapy. Approximately 50 patients will be enrolled into each treatment arm.
Main Criteria for Inclusion: Inclusion criteria for this study specify that patients have evaluable, biopsy-proven, surgically unresectable, regionally advanced, or metastatic urothelial cancer of the bladder, ureter, or renal pelvis. Additionally, patients must have an Eastern Cooperative Oncology Group performance status of 0-2 and adequate bone marrow, renal, and hepatic function. Patients who have undergone previous systemic chemotherapy will be excluded from this study.
Test Product, Dose, Mode of Administration: All patients will receive chemotherapeutic treatment with cisplatin (70 mg/kg) intravenously on Day 1 and gemcitabine (1000 mg/m2) intravenously on Days 1, 8, and 15 of each 21-day cycle. Patients will be randomized to receive either Leukine (250 µg/m2) or Neupogen (5 µg/kg) subcutaneously on Days 2-6, 9-13, and 16-20 of each cycle.
Duration of Treatment: Patients will receive a maximum of six 21-day cycles of treatment. The overall trial, including follow-up, is expected to be 3 years in duration.
Criteria for Evaluation: Efficacy will be assessed by, incidence of grade 3 and 4 toxicities, evaluation of complete and partial response, time to progression, overall and disease specific survival, planned vs administered doses, and quality of life. Safety will be assessed by, vital signs, physical examinations, clinical laboratory evaluations, and the reporting of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Biopsy-proven, regionally advanced (T4b, N2, N3), or metastatic (M1) urothelial cancer of the bladder, ureter, or renal pelvis
- A minimum of one target lesion according to the RECIST criteria (Appendix D). Note: Bone metastases, leptomeningeal disease, ascites, pleural or pericardial effusions, lymphangitic spread or cystic lesions are not acceptable as target lesions.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Appendix B).
- Age >/=18 years or the age of majority in the state of the participating institution.
- Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter. Post menopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
Key exclusion criteria (8 listed)
- Undergone previous systemic chemotherapy.
- Major surgery <4 weeks prior to study treatment start, or lack of complete recovery from major surgery.
- Participation in any investigational drug study within 4 weeks preceding treatment start.
- History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be significant enough to preclude informed consent or interfering with compliance for oral drug intake.
- Previous history of cancer unless treatment was curative and completed >/=5 years prior to entry onto study, or unless diagnosed as one of the following: in situ carcinoma (any location), basal cell carcinoma, or non-metastatic squamous cell carcinoma of the skin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabine | Drug | – |
| cisplatin | Drug | – |
| sargramostim | Drug | – |
| filgrastim | Drug | – |
Primary outcome
Efficacy of Leukine & Neupogen to prevent grade 3 & 4 neutropenia in patients receiving cisplatin & gemcitabine: assessed before cycles 3 & 5, then at end of treatment.
Safety of Leukine & Neupogen: evaluated before each cycle & blood work is evaluated weekly throughout the study.
6 secondary outcomes
Reduction of grade 3 & 4 hematologic toxicities: evaluated weekly throughout the study.
Reduction of clinical hematologic toxicity including the # of: hospital days required for febrile neutropenia, transfusions & bleeding events, & days of outpatient antibiotics: evaluated throughout the study treatment and until resolved.
Reduction of non-hematologic toxicities: evaluated prior to each cycle.
Enhancement of anti-tumor effects (CR & PR, time to progression, OS & DFS): assessed before cycles 3 & 5, then on day 22 of cycle 6.
Dose intensity as planned vs administered: assessed during each treatment.
Quality of life: evaluated at baseline, pre-cylces 3 & 5, & end of treatment.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Rinehart, MD study chair
University of Kentucky
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gemcitabine, cisplatin and sargramostim in people with Bladder Cancer, run by University of Kentucky at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Leukine & Neupogen to prevent grade 3 & 4 neutropenia in patients receiving cisplatin & gemcitabine: assessed before cycles 3 & 5, then at end of treatment.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2012.