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

This study has been terminated.
Sponsor:
Collaborators:
Bayer
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00522301
First received: August 28, 2007
Last updated: March 15, 2013
Last verified: March 2013
  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
Primary Peritoneal Cavity Cancer
Drug: sorafenib tosylate
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Progression-free survival (PFS) rate at 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of prolonged treatment as assessed by NCI CTCAE v3.0 in patients with a history of recurrent ovarian cancer [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Correlation of serum markers of angiogenesis (i.e., VEGF and bFGF) as assessed by ELISA and tumor markers (i.e., pAKT, HIF-1 α, and VEGF) as assessed by IHC with the 12-month PFS rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: July 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522301

Locations
United States, New York
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Bayer
Investigators
Principal Investigator: William P. Tew, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Paul Sabbatini, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00522301     History of Changes
Other Study ID Numbers: 07-080, P30CA008748, MSKCC-07080, BAYER-MSKCC-07-080
Study First Received: August 28, 2007
Last Updated: March 15, 2013
Health Authority: United States: Institutional Review Board

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:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Neoplasms by Histologic Type
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014