Trial 0C-10-3

Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) in Advanced Solid Tumor Patients with Varying Degrees of Hepatic Impairment.

Type: Cancer Therapy
Phase: Phase I
Status: Open to Accrual
Treatments: Chemotherapy: Systemic
Randomized: No
Defintions of terms and FAQ about clinical trials.

Trial Leaders/Researchers: David Quinn, M.D.
Other Trial Staff: Mary Ordaz, D.M., Anayansi Miloud, D.M., Xiomara Menendez, R.N., Jubilee Acap, R.N.

Staff may log in to see study documents.

You may participate in this study if:

	Requirement
1	Metastatic or locally advanced non-hematologic cancer, for which no effective curative therapy is available, i.e., patients who are refractory to or have progressed following standard therapies
2	Measurable and non-measurable dz
3	Male and female patients at least 18 years of age with varying degrees of liver impairment
4	ECOG performance status 0, 1, or 2
5	Life expectancy at least 3 months
6	AGC = / > 1.5; platelets = / > 75,000; Hgb = / > 9.0
7	INR < / = 1.3
8	Albumin = / > 3.0
9	Creatinine < / = 1.5 mg/dl or < / = 1.5 x uln
10	Patients with biliary obstruction for which a shunt has been placed are eligible, provided the shunt has been in place for at least 10 days prior to the first infusion of study medication and liver function has stabilized (as evidenced by 2 bilirubin and LFT measurements at least 2 days apart that put the patient in the same hepatic dysfunction stratum) without evidence of biliary sepsis
11	Signed an approved study-specific informed consent and HIPAA

You may not participate in this study if:

1	Anticipation of need for a major surgical procedure or radiation therapy during the study
2	Not willing or able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
3	Prior chemotherapy, other investigational drug, biological therapy, targeted non-cytotoxic therapy and radiotherapy within 3 weeks prior to registration
4	Concurrent treatment in another clinical trial or with any other cancer therapy including chemotherapy, biological therapy, RT, chemoembolization therapy, cryotherapy, targeted non-cytotoxic therapy or patients planning to receive these treatments during the study
5	Other concurrent serious illness or medical condition, including active infection or HIV
6	Evidence of another active malignancy
7	Non-resolution of all clinically significant toxic effects (excluding alopecia) of any prior therapy to = / < Gr 1 or to within the limits listed in the specific inclusion/exclusion criteria
8	Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient’s safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
9	Pregnant or breastfeeding women. Women of childbearing potential must use a highly effective contraceptive method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration. Fertile men must be willing to use contraception. Acceptable methods of contraception include any two or more of the following methods: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double- barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
10	Known brain or leptomeningeal metastases. CT or MRI of brain is required only in case of clinical suspicion of CNS involvement. Patients with treated and controlled lesions are eligible.
11	Known history of Gilbert’s syndrome
12	Exclusion criteria related to cabazitaxel: [1] Prior treatment with cabazitaxel. [2] History of severe (= / > Gr 3) hypersensitivity to taxanes, polysorbate-80, or to compounds with similar chemical structures. [3] Concurrent treatment with strong inhibitors of cytochrome P450 3A4 or patients planning to receive these treatments.

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.