Randomized Phase III Trial of Leukine® vs Neupogen® in Patients Receiving Cisplatin & Gemcitabine for Urothelial Cancer

NCT00237575 | Terminated Phase 3

• 1 other identifier: 04-GU-53B
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Bladder Cancer

Keywords

urothelial; bladder; gemcitabine; cisplatin; leukine; neupogen; filgrastim; sargramostim; metastatic; Regionally Advanced; Advanced

Outcome Measures

Primary Outcomes (2)

• 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.

Interventions

gemcitabine DRUG

cisplatin DRUG

sargramostim DRUG

filgrastim DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kentucky: lead
• Bayer: collaborator

Study Sites (4)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University of Nebraska

Omaha, Nebraska, 68198-7680, United States

Location

New York Medical College

Hawthorne, New York, 10532, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Neoplasm Metastasis

Interventions

Gemcitabine; Cisplatin; sargramostim; Filgrastim

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• John Rinehart, MD

  University of Kentucky

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2005
• First Posted: October 12, 2005
• Study Start: November 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: May 23, 2012

Record last verified: 2012-05

Locations

US (4)