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

Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bladder Cancer

Intervention: Gemcitabine (Drug); Carboplatin (Drug); Sorafenib (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Hari Deshpande, MD, Principal Investigator, Affiliation: Yale University

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.

Clinical Details

Official title: A Phase II, Multicenter Trial of Gemcitabine, Carboplatin, and Sorafenib in Chemotherapy-naive Patients With Advanced/Metastatic Bladder Carcinoma

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To evaluate the time to disease progression in patients with advanced/metastatic TCC treated with the combination of sorafenib, gemcitabine, and carboplatin.

Secondary outcome:

To determine the overall safety and tolerability of combination therapy with sorafenib, gemcitabine and carboplatin

To define the proportion of patients with advanced or metastatic transitional cell carcinoma of the bladder that achieve a complete or partial response to the combination therapy with sorafenib, gemcitabine, and carboplatin.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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)

- INR < 1. 5 or a PT/PTT within normal limits. Patients receiving anti-coagulation

treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable. Exclusion Criteria:

- 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

- Major surgery, significant traumatic injury within 4 weeks of first study drug

- Use of St. John's Wort or rifampin (rifampicin)

- Known or suspected allergy to sorafenib or any agent given in the course of this

trial

- Any condition that impairs patient's ability to swallow whole pills

- Any malabsorption problem

- Anticipation of need for major surgical procedure during the course of the study

- Pregnant (positive pregnancy test) or lactating

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal

abscess within 6 months prior to Day 0

- Serious, non-healing wound, ulcer, or bone fracture

- Inability to comply with study and/or follow-up procedures

- History of persistent gross hematuria

Locations and Contacts

Yale University, Comprehensive Cancer Center, New Haven, Connecticut 06520, United States
Additional Information

Starting date: March 2007
Last updated: June 22, 2014

Page last updated: August 23, 2015

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