Trial of Gemcitabine, Carboplatin, and Sorafenib in Chemotherapy-naive Patients With Advanced/Metastatic Bladder Carcinoma

NCT00461851 | Completed Phase 2 Results

• 1 other identifier: 0609001823
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II, nonrandomized multicenter study designed to evaluate time to progression and response proportion of patients with advanced or metastatic transitional cell carcinoma of bladder receiving 6 cycles of gemcitabine, carboplatin and sorafenib and then maintenance sorafenib.

Conditions

Bladder Cancer

Keywords

Advanced/Metastatic Bladder Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  The primary outcome was the proportion of patients who achieved progression free survival (PFS) of five months. PFS was defined as time to progression or any-cause mortality, whichever came first.

  Upon completion of study

Secondary Outcomes (2)

• Dose Ruction (Toxicity)

  Upon completion of study

• Best Reported Response

  Upon completion of study

Study Arms (1)

Chemotherapy plus sorafenib

EXPERIMENTAL

Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone

Drug: Gemcitabine; Drug: Carboplatin; Drug: Sorafenib

Interventions

Gemcitabine DRUG

Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.

Also known as: Gemzar

Chemotherapy plus sorafenib

Carboplatin DRUG

Carboplatin will be given on day 1 to an AUC of 5.

Chemotherapy plus sorafenib

Sorafenib DRUG

Sorafenib will be administered orally daily on days 2-19 at 400 mg bid

Also known as: BAY 43-9006

Chemotherapy plus sorafenib

Eligibility Criteria

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

You may qualify if:

• Histologic documentation of diagnosis of transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis
• Unresectable, locally advanced or metastatic disease
• CrCl ≥ 60 ml/min or serum creatinine \< 1.5
• ≥ 4 weeks since prior RT
• ECOG Performance Status of 0 or 1 (Appendix I)
• Age ≥ 18 years of age
• Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men and women should use adequate birth control for at least 2 weeks after the last administration of sorafenib.
• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
• Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
• Adequate bone marrow, liver and renal function as assessed by the following:
• Hemoglobin \> 9.0 g/dl
• Absolute neutrophil count (ANC) ≥ 1,500/mm3
• Platelet count ≥ 100,000/mm3
• Total bilirubin ≤ 1.5 times ULN
• ALT and AST ≤ 2.5 times the ULN ( ≤ 5 x ULN for patients with liver involvement)

You may not qualify if:

• Prior treatment with systemic chemotherapy (prior intravesical chemotherapy is permitted, and adjuvant therapy is permitted if \> 12 months have lapsed)
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
• Cardiac disease: Congestive heart failure \> class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
• History of stroke within six months
• Clinically significant peripheral vascular disease
• Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
• Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients.
• Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
• Active clinically serious infection \> CTCAE Grade 2.
• Thrombolytic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
• Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug
• Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug
• Evidence or history of bleeding diathesis or coagulopathy

Sponsors & Collaborators

• Yale University: lead
• Bayer: collaborator

Study Sites (1)

Yale University, Comprehensive Cancer Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Gemcitabine; Carboplatin; Sorafenib

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Results Point of Contact

• Title: Dr Michael Hurwitz
• Organization: Yale University Yale Cancer Center

Hari.deshpande@yale.edu

2037371600

Study Officials

• Hari Deshpande, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 18, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 14, 2017
• Results First Posted: November 1, 2016

Record last verified: 2016-09

Locations

US (1)