Cisplatin and Gemcitabine Hydrochloride (Chemotherapy drugs) with and without ATR Kinase Inhibitor VX-970 (experimental medicine)

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"Study looking at Chemotherapy treatment with and without experimental medicine for bladder/ureothelial cancer"
Age:
18 to 100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
Bladder cancer, urothelial cancer, chemotherapy
Type:
Drug study, Phase 2
Investigator:
Description
This study looks at how well cisplatin and gemcitabine hydrochloride, with or without ATR kinase inhibitor VX-970 works in treating patients with urothelial cancer that has spread to other places in the body. Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. ATR kinase inhibitor VX-970 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin and gemcitabine hydrochloride work better alone or with ATR kinase inhibitor VX-970 in treating patients with urothelial cancer.
This study requires
Contact for more details
Who can participate?
Inclusion Criteria:

- Patients must have histologically or cytologically confirmed metastatic urothelial carcinoma; urothelial cancer derived from the bladder, ureter or upper tract is permitted

- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam

- Patients must have access to archival tumor tissue for proposed correlative studies; these may be derived from transurethral resection of bladder tumors (TURBT), cystectomy, or biopsy; if archival tissue is not available for proposed correlatives, patients may be enrolled at the discretion of the study principal investigator (PI) (SKP)

- No prior cytotoxic chemotherapy for metastatic disease

- At least 12 months have elapsed since platinum-based peri-operative treatment

- Karnofsky >= 70% (Eastern Cooperative Oncology Group [ECOG] performance status 0-1)

- Life expectancy of greater than 3 months

- Leukocytes >= 3,000/mcL

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal

- Creatinine clearance >= 50 mL/min by either measured or calculated clearance

- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of VX-970 administration

- Ability to understand and the willingness to sign a written informed consent document


Exclusion Criteria:

- Radiotherapy within 4 weeks of protocol therapy

- Patients who are receiving any other investigational agents

- History of allergic reactions attributed to compounds of similar chemical or biologic composition to VX-970, cisplatin, or gemcitabine

- Concomitant administration with strong inhibitors or inducers of CYP3A4 should be avoided; it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with VX-970; these potential risks may also apply to other agents used in this study

- Patients with >= grade 2 neuropathy
Resources
Schedule
Study duration and period
Contact for more details
Recruitment period
From Oct. 5, 2016
Location
UC Davis Comprehensive Cancer Center
2279 45th Street
Sacramento, CA 95817
Contact
Primo Lara, MD
Research Topic
Conditions:
  • Metastatic Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Stage IV Bladder Urothelial Carcinoma

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