MDACC Study Summary 2004-0970

Study Summary
No. 2004-0970:.......Ovary......Siqing Fu......Investigational Cancer Therapeutics

Study Summary Title



Study Summary Number:	2004-0970

Study Title:	A Pilot Pharmacodynamic Trial Using Molecular Marker and Imaging Studies as Primary Endpoints to Determine the Optimal Biological Dosage of Perifosine, an Orally Available AKT PH Domain Inhibitor, Combined with Docetaxel in Patients with Relapsed Epithelial Ovarian Cancer

Physician

New Patient Referral



Name:	Siqing Fu	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Investigational Cancer Therapeutics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-1930 Contact us about clinical trials

General Information



Disease Group:	Ovary	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Once every four weeks

Treatment Agents:	Docetaxel Perifosine	Home Care:	NA

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	NA


Description/ Intervention:	The goal of this clinical research study is to find out if a combination treatment of perifosine and docetaxel will help shrink or slow the growth of cancer cells in recurrent ovarian cancer. The safety of this combination treatment will also be studied.

Study Objectives / Outcomes

The Primary Objective of This Study

The primary objective of this study is to determine the biologically relevant dosage of perifosine in patients with relapsed epithelial ovarian cancer by comparison of the following measures between prior to and after treatment with single agent perifosine during the first cycle:

a. Molecular marker analyses of primary tumor tissues, blood nuclear monocytes and hair follicle samples for the PI3K/PTEN-AKT pathway assays.

b. Imaging studies of MRI for vascular permeability measurement and PET scan for tumor viability and glucose uptake assessment;

In addition, we will evaluate all the enrolled patients who receive either single agent perifosine during the first cycles or a combination of perifosine plus docetaxel during subsequent cycles of treatment:

a. Biological marker assays of blood samples for CA125, IL8, IL6, and VEGF;

b. Clinical assessment for toxicity profile and possible dose limited toxicity.

The Secondary Objective of This Study

The secondary objective is to assess tumor responses; to predict early responses by molecular marker and imaging studies, and to determine whether this trial will move forward to a phase II efficacy study.

Study Status Information



Study Activation / Registration Date:	02/01/2007

IRB Review and Approval Date:	12/07/2005

Study Type:	Phase I

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patient has histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube cancer or gynecologic primary peritoneal cancer. All patients must be platinum resistant or refractory that is defined as tumor progression during platinum-based treatment or less than 6 months of treatment-free interval.

2) All patients have to have tumor that is accessible to biopsy. In addition, patients have to have another tumor that a) will not be biopsied; and for the purpose of DCE-MRI and PET studies, b) is at least 2cm in size per radiologic measurement.

3) Patient is at least 18 years of age.

4) Patient has an ECOG performance status of 0-2.

5) Patient is willing to comply with study procedures to have biopsies of tumor and blood collection for molecular marker and biological marker studies; and two PET scans and two dynamic MRIs for imaging studies and follow-up examinations for toxicity profile.

6) Patients must be informed of the investigational nature of this study and give written IRB-approved informed consent according to institutional guidelines.

7) If patient is of child-bearing potential, she has agreed to practice an effective method of birth control during the study and 6 months after the last study dose.

8) Patient has adequate liver and renal function: serum bilirubin =/<2.0 mg/dL; ALT=/<3x uln. If the patient has hepatic metastasis, ALT =/<5x uln. Serum creatinine =/<2.0 mg/dL or a calculated creatinine clearance of at least 50 ml/min.

9) Patient has adequate bone marrow reserve. ANC=/>1,500/mm^3, Platelet count =/>100,000/mm^3, and Hemoglobin =/>9.0g/dL without bone marrow support.

Exclusion Criteria:

1) Any concurrent chemotherapy.

2) Underlying medical condition that might be aggravated by treatment or that cannot be controlled, i.e. active uncontrolled infection and cardiac dysfunction.

3) Medical and psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk.

4) Known hypersensitivity to study drugs or its analogs.

5) Failure to recover from any prior surgery within 4 weeks of study entry.

6) Pregnant or lactating.

7) On combination anti-retroviral therapy for HIV because of possible pharmacokinetic interaction with perifosine. Every effort will be made to avoid known inhibitors or inducers of P450 enzymes for potential drug-drug interaction.

8) Any treatment specific for tumor control within 3 weeks of study drugs (within 6 wks. for nitrosoureas or mitomycin C) or failure to recover from the toxic effect of any of these therapies prior to study entry.

9) Any signs of intestinal obstruction interfering with nutrition. Patient cannot tolerate oral intake for any reason.

10) A known history of CNS metastasis unless the patient has had treatment with surgery or radiation therapy, is neurologically stable, and does not require oral or intravenous corticosteroids or anticonvulsants.

11) Any investigational drug within 30 days of first day of dosing.

12) History of high-dose chemotherapy for ovarian cancer, defined as the intensity and/or the density of a chemotherapeutic agent beyond standard of care for ovarian cancer treatment. i.e. Treatment with carboplatin at AUC 11 is considered as high-dose chemotherapy.

Links

Registration Number: NCT00431054
Study Information on Clinical Trials Registry (clinicaltrials.gov)