Perifosine and Docetaxel in Patients With Relapsed Epithelial Ovarian Cancer

NCT00431054 | Completed Phase 1

• 1 other identifier: 2004-0970
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer; Perifosine; Docetaxel; Taxotere

Outcome Measures

Primary Outcomes (1)

• Tumor Response

  After the end of every 2 cycles (about every 8 weeks), an x-ray and either a CT scan or an MRI will be obtained to re-evaluate tumor response.

Study Arms (1)

Perifosine + Docetaxel

EXPERIMENTAL

Drug: Perifosine; Drug: Docetaxel

Interventions

Perifosine DRUG

Loading Dose = 100 mg by mouth (PO) every 6 hours, followed by 50 mg by mouth (PO) daily

Perifosine + Docetaxel

Docetaxel DRUG

75 mg/m\^2 by vein over 1 hour every 4 weeks

Also known as: Taxotere

Perifosine + Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Patient is at least 18 years of age.
• Patient has an ECOG performance status of 0-2.
• 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.
• Patients must be informed of the investigational nature of this study and give written IRB-approved informed consent according to institutional guidelines.
• 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.
• 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.
• 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.

You may not qualify if:

• Any concurrent chemotherapy.
• Underlying medical condition that might be aggravated by treatment or that cannot be controlled, i.e. active uncontrolled infection and cardiac dysfunction.
• Medical and psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk.
• Known hypersensitivity to study drugs or its analogs.
• Failure to recover from any prior surgery within 4 weeks of study entry.
• Pregnant or lactating.
• 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.
• 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.
• Any signs of intestinal obstruction interfering with nutrition. Patient cannot tolerate oral intake for any reason.
• 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.
• Any investigational drug within 30 days of first day of dosing.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Keryx Biopharmaceuticals: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

perifosine; Docetaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• David S. Hong, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2007
• First Posted: February 5, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 19, 2016

Record last verified: 2012-06

Locations

US (1)