Trial 11S-10-1

Randomized, Phase II Trial of AZD6244 Alone and AZD6244 plus Temsirolimus for Soft-Tissue Sarcomas.

Type: Cancer Therapy
Phase: Phase II
Status: Closed to Accrual with Ongoing Follow-up
Treatments: Chemotherapy: Systemic
Randomized: Yes
Defintions of terms and FAQ about clinical trials.

Trial Leaders/Researchers: James Hu, M.D.
Other Trial Staff: Charlean Ketchens, R.N., Lagrimas Ilagan, D.M., Ernesto Duverger, D.M., Ernesto Duverger, D.M.

Staff may log in to see study documents.

You may participate in this study if:

	Requirement
1	Histologic verification of soft tissue sarcoma at original diagnosis that is metastatic (de novo or recurrent) or locally advanced, unresectable disease
2	Measurable disease
3	Age > 18 years
4	ECOG performance status 0-2 (Karnofsky at least 50%)
5	Estimated life expectancy > 12 weeks
6	AGC = / > 1.0; platelets = / > 100,000 (transfusion dependent); Hgb = / > 8.0 (may receive RBC transfusions)
7	Total bilirubin < / = 1.5 x uln; SGPT < / = 5 xuln; albumin = / > 2 gm/dl
8	Creatinine < / = 1.5 x uln or calculated CrCl = / > 45 ml/min
9	May have received 0-2 prior chemotherapeutic regimens (single-agent or combination chemotherapies)
10	Signed an approved study-specific informed consent and HIPAA

You may not participate in this study if:

1	Evidence of dyspnea at rest; exercise intolerance. Pulse oximetry > 94% if there is clinical indication for determination.
2	Concomitant Medications: [1] Receiving growth factors within the past 7 days. [2] Patients with CNS tumors who have not been on a stable or decreasing dose of dexamethasone for the past 7 days. [3] Currently receiving another investigational drug. [4] Currently receiving other anti-cancer agents. At least 3 weeks must have elapsed since prior chemotherapy or radiation (6 weeks for mitomycin-C and nitrosureas).
3	Known brain mets
4	History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244
5	Previous MEK inhibitor use
6	QTc interval > 450 msecs or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome)
7	Unable to swallow the AZD6244 capsules
8	Refractory nausea and vomiting, chronic GI diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
9	Uncontrolled intercurrent illness including, but not limited to, uncontrolled, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
10	Pregnant or nursing women. For women: must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen (e.g., IUD, birth control pills, or barrier device) during and until 4 weeks after the last dose of study treatment; must have a negative serum or urine pregnancy test within 7 days before study enrollment, and must not be breastfeeding. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform her treating physician immediately. For men: must be surgically sterile or compliant with a contraceptive regimen during and for 16 weeks after the treatment period. Please note that the AZD6244 manufacturer recommends that adequate contraception for male patients should be used for 16 weeks post-last dose due to sperm life cycle.
11	HIV-positive patients on combination antiretroviral therapy
12	Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
13	Prior cardiac history of uncontrolled HTN, NYHA > Class II, current or prior cardiomyopathy, baseline LVEF <50%, ongoing AF, recent MI, or unstable ischemic heart disease
14	Concomitant strong CYP1A2 or CYP3A4 inducers and/or inhibitors

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.