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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00522301 |
Purpose
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer in at least the second remission.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: sorafenib tosylate Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial of Oral Sorafenib (Bay43-9006) In Women With Epithelial Ovarian, Fallopian Tube Or Peritoneal Carcinoma In Second Or Greater Remission |
| Estimated Enrollment: | 35 |
| Study Start Date: | July 2007 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral sorafenib twice a day on days 1-28. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection at baseline, every 12 weeks during study, and after completion of study therapy for pharmacokinetic studies. Samples are analyzed for soluble markers of angiogenesis (i.e., VEGF and bFGF) via ELISA and HIF-1 α, VEGF, and pAKT via IHC staining.
After completion of study treatment, patients are followed at 4 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum
Must have received initial cytoreductive surgery and chemotherapy with ≥ 1 platinum-based chemotherapy regimen
In complete clinical remission after chemotherapy for recurrent disease, meeting all of the following criteria:
No definite evidence of disease by CT scan of the abdomen and pelvis
PATIENT CHARACTERISTICS:
Inclusion criteria:
Urinalysis negative for protein
If urinalysis shows 1+ protein by dipstick or protein ≥ 30-100 mg/dL by semi-quantitative assay, a 24-hour urine collection is required
Exclusion criteria:
Uncontrolled concurrent illness or medical condition including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
Major surgery (i.e., laparotomy) within the past 4 weeks or minor surgery within the past 2 weeks
Contacts and Locations| United States, New York | |
| Memorial Sloan - Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | William P. Tew, MD | Memorial Sloan-Kettering Cancer Center |
| Investigator: | Paul Sabbatini, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan-Kettering Cancer Center ( William Patrick Tew ) |
| Study ID Numbers: | CDR0000562238, MSKCC-07080, BAYER-MSKCC-07-080 |
| Study First Received: | August 28, 2007 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00522301 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer stage I ovarian epithelial cancer |
stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
|
Fallopian Tube Cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer Abdominal Neoplasms Protein Kinase Inhibitors Fallopian Tube Neoplasms |
Recurrence Fallopian Tube Diseases Carcinoma Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Sorafenib Endocrine Gland Neoplasms |
|
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Urogenital Neoplasms Ovarian Diseases Protein Kinase Inhibitors Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms |
Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Abdominal Neoplasms Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Peritoneal Neoplasms Sorafenib |