Sorafenib in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in at Least the Second Remission

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00522301
Recruitment Status : Terminated
First Posted : August 29, 2007
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: sorafenib tosylate Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study Phase 2

Detailed Description:



  • To determine the 12-month progression-free survival (PFS) rate of women with ovarian epithelial, fallopian tube, or peritoneal cancer in second or greater remission treated with oral sorafenib tosylate.


  • To determine the safety and tolerability of prolonged treatment with oral sorafenib tosylate in women with a history of recurrent ovarian cancer.
  • To correlate serum markers of angiogenesis (i.e., VEGF and bFGF) and tumor markers pAKT, HIF-1 α , and VEGF with 12-month PFS.

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Arm Intervention/treatment
Experimental: Oral Sorafenib (BAY43-9006)
Sorafenib is supplied as 200-mg tablets. Sorafenib will be administered as 400 mg orally daily x 28 days (continuous). One cycle = 28 days. There is no planned treatment interruption between cycles. Sorafenib should be taken without food (at least 1 hour before or 2 hours after eating). In the absence of intolerable toxicity, a patient may continue to receive treatment with sorafenib until disease progression, or until 24 months have elapsed.
Drug: sorafenib tosylate
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study

Primary Outcome Measures :
  1. Progression-free Survival (PFS) Rate at 12 Months [ Time Frame: 1 year ]
    All 5 patients experienced a rash. As a result, all 5 were either advised to withdraw from the protocol, or withdrew themselves from the protocol. The outcome was not met.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum

    • Any stage and grade at diagnosis
  • Must have received initial cytoreductive surgery and chemotherapy with ≥ 1 platinum-based chemotherapy regimen

    • Persistent or recurrent disease after initial therapy
  • In complete clinical remission after chemotherapy for recurrent disease, meeting all of the following criteria:

    • CA125 ≤ 35 units/L
    • Normal physical examination
    • No definite evidence of disease by CT scan of the abdomen and pelvis

      • Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm are not considered definite evidence of disease
  • No known brain metastases


Inclusion criteria:

  • Karnofsky performance status 70-100%
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • INR < 1.5 OR PT/PTT within normal limits
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • 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

      • Eligible patients must have a total urinary protein ≤ 500 mg AND measured creatinine clearance ≥ 50 mL/min from a 24-hour urine collection
  • Bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Stable blood pressure (BP) measurement required on 3 separate days prior to the start of treatment
  • No peripheral neuropathy > grade 1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Exclusion criteria:

  • Other invasive malignancies within the past 5 years, except nonmelanoma skin cancer
  • Uncontrolled concurrent illness or medical condition including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Uncontrolled diabetes
  • Psychiatric illness or social situation that would preclude study compliance
  • Uncontrolled hypertension defined as a persistent BP > 150/100 mm Hg (or a persistent BP > 180/90 mm Hg if the patient has a history of isolated systolic hypertension) despite ≥ 2 attempts at antihypertensive medication dosage adjustment ≥ 2 weeks apart
  • Thrombolic or embolic events such as cerebrovascular accident, including transient ischemic attack, within the past 6 months
  • Pulmonary hemorrhage or bleeding event ≥ grade 2 within 4 weeks of the first dose of study drug
  • Other hemorrhage or bleeding event ≥ grade 3 within 4 weeks of the first dose of study drug
  • Serious nonhealing wound, ulcer, or bone fracture
  • Evidence or history of bleeding diathesis or coagulopathy
  • Inability to take oral medications or gastrointestinal condition that compromises absorption
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib tosylate


Inclusion criteria:

  • See Disease Characteristics
  • No prior sorafenib tosylate or other inhibitors of MAPK signaling intermediates or angiogenesis inhibitors
  • No prior cancer treatment that would contraindicate protocol therapy
  • More than 4 weeks since prior radiotherapy
  • More than 3 weeks since prior chemotherapy, biological therapy, or immunotherapy
  • More than 1 week since prior hormonal therapy for cancer treatment

Exclusion criteria:

  • Major surgery (i.e., laparotomy) within the past 4 weeks or minor surgery within the past 2 weeks

    • Placement of a vascular access device is not considered minor surgery
  • Concurrent combination antiretroviral therapy for HIV-positive patients
  • Concurrent St. John wort, rifampin, or enzyme-inducing anticonvulsants (e.g., carbamazepine, phenytoin, or phenobarbital)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00522301

United States, New York
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: William P. Tew, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Paul Sabbatini, MD Memorial Sloan Kettering Cancer Center

Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00522301     History of Changes
Other Study ID Numbers: 07-080
P30CA008748 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2007    Key Record Dates
Results First Posted: February 29, 2016
Last Update Posted: February 29, 2016
Last Verified: February 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs