Trial 4B-10-4

Single Arm Phase II Study of Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder as Second-Line Treatment.

Type: Cancer Therapy
Phase: Phase II
Status: Closed to Accrual with Ongoing Follow-up
Treatments: Chemotherapy: Systemic
Randomized: No
Defintions of terms and FAQ about clinical trials.

Trial Leaders/Researchers: David Quinn, M.D.
Other Trial Staff: Charlean Ketchens, R.N., Lagrimas Ilagan, D.M., Jolie Solomon, R.N., Carrie Korn, R.N., Honorina Enright, D.M.

Staff may log in to see study documents.

You may participate in this study if:

	Requirement
1	Histologically or cytologically confirmed transitional cell carcinoma of the urothelium (also called urothelial cancer). Mixed histologies are allowed as long as the predominant histology is TCC. In addition, tumor tissue must be available for evalautuon for EGFR and HER2/neu status.
2	Locally recurrent or advanced, non-resectable or stage IV transitional cell carcinoma
3	Prior platinum salt-based chemotherapy for TCC. Other prior systemic chemotherapeutic or investigational treatment regimens for TCC are allowed. May have had up to 3 lines of chemotherapy for advanced disease. May have had paclitaxel provided their cancer did not progress while on it; and it was part of an adjuvant or neoadjuvant regimen. Prior targeted or biological therapy is permitted, except for drugs targeting EGFR and/or HER2. Specifically, subjects must meet one or more of the following criteria: (a) Progression after treatment with a regimen that includes a platinum salt (e.g., carboplatin or cisplatin) for Stage IV or recurrent disease; OR, (b) Disease recurrence within two years (from the date of last dose of chemotherapy or surgery until day the informed consent is signed) of neoadjuvant or adjuvant treatment with a regimen that includes a platinum salt.
4	Measurable or evaluable disease
5	At least 18 years of age
6	ECOG performance status 0 or 1
7	AGC = / > 1.5; platelets = / > 100,000
8	Bilirubin < / = 1.5 x uln (except in patients with Gilbert’s disease)
9	Serum K and Mg within nl
10	SGOT, SGPT, alk phos < / = 2.5 x uln (see table Sect. 5.3.3.d)
11	Creatinine clearance = / > 30 ml/min
12	LVEF within nl range as measured by echocardiogram or MUGA scan
13	Signed an approved study-specific informed consent and HIPAA

You may not participate in this study if:

1	History of treatment of TCC (in any setting – neoadjuvant, adjuvant or for metastatic disease) with Docetaxel
2	History of treatment with an EGFR or HER2 targeted agent
3	Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator’s opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol
4	Clinically significant cardiac event such as MI; NYHA classification of heart disease >2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia
5	History of arrhythmia (multi-focal PVCs, bigeminy, trigeminy, ventricular tach, or uncontrolled AF which is symptomatic or requires treatment, or asymptomatic sustained ventricular tach. AF controlled on medication is not exclusion nor are infrequent or unifocal ectopic beats.
6	Current QTc prolongation as a result of medication will require discontinuation of that medication. Patient can be re-assessed after discontinuation, provided this is medically appropriate, after 2 weeks or five half-lives of the drug have past which ever is longer.
7	Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age
8	Presence of LBBB
9	QTc with Bazett’s correction that is unmeasurable, or exceeds 480 msec on screening ECG
10	Any concomitant medication that may cause QTc prolongation, induce Torsades de Pointes or induce CYP3A4 function
11	HTN not controlled by medical therapy
12	Currently active diarrhea
13	Pregnant or breastfeeding women. Subjects with reproductive potential must use adequate contraceptive methods. Females with reproductive potential must have a negative serum pregnancy test within 7 days of study entry. Female subjects must be one year post-menopausal, surgically sterile, or using an acceptable method of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, IUD, or tubal ligation.) Male subjects must be surgically sterile or using an acceptable method of contraception during their participation in this study.
14	Receipt of any investigational agent, chemotherapy, or RT within 21 days prior to study Day 1
15	Any unresolved non-hematologic toxicity > Gr 1 from previous anti-cancer therapy (other than alopecia)
16	Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy
17	Grade 2 or greater peripheral neuropathy
18	Previous or current malignancies within the last 3 years, except in-situ cervical carcinoma, adequately treated skin carcinoma, small renal masses, and adequately treated localized prostate cancer. Other cancers that are highly likely to be cured (cure rate of 75% or greater) may be included at the discretion of the PI.
19	History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
20	Patients with brain metastasis can only be included if they were treated > 4 week prior to enrollment

For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.