Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00093626
First received: October 6, 2004
Last updated: February 11, 2014
Last verified: January 2013
  Purpose

Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. This phase II trial is studying how well sorafenib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer.


Condition Intervention Phase
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Drug: sorafenib tosylate
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of BAY 43-9006 (Sorafenib, Nexavar®, NCI-Supplied Agent, NSC #724772, IND #69,896) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Will be evaluated using proportional hazards modeling and Fisher's exact test.

  • Frequency and severity of adverse events as assessed by CTCAE v3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of clinical response (complete and partial response) defined by RECIST criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Duration of progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be evaluated using proportional hazards modeling and Fisher's exact test.

  • Duration of overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be evaluated using proportional hazards modeling and Fisher's exact test.

  • Prognostic variables (platinum sensitivity, performance status, and cellular histology [clear cell or mucinous type]) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: October 2004
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: sorafenib tosylate
Given orally
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the efficacy of sorafenib in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma.

II. Determine 6-month progression-free survival of patients treated with this drug.

III. Determine the toxicity of this drug, in terms of frequency and severity of adverse events encountered, in these patients.

SECONDARY OBJECTIVES:

I. Determine the clinical response rate (partial and complete response) in patients treated with this drug.

II. Determine the duration of progression-free and overall survival of patients treated with this drug.

III. Correlate prognostic variables (platinum sensitivity, performance status, and histology [clear cell and mucinous type]) with response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within 6-13 months.

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed ovarian epithelial or primary peritoneal carcinoma

    • Persistent or recurrent disease
  • Measurable or evaluable disease

    • Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (including palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
    • Evaluable disease is defined as at least 1 of the following:

      • CA 125 ≥ 2 times upper limit of normal (ULN)
      • Ascites and/or pleural effusion attributed to tumor
      • Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST definition for target lesions
  • Must have received 1 prior platinum-based chemotherapeutic regimen for primary disease, including carboplatin, cisplatin, or another organoplatinum compound

    • Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
    • Platinum-resistant according to 1 of the following criteria:

      • Treatment-free interval of < 12 months after platinum therapy
      • Disease progression during platinum-based therapy
      • Persistent disease after a platinum-based regimen
  • Ineligible for higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population)
  • No brain metastases
  • Performance status - GOG 0-2 (for patients who received 1 prior treatment regimen)
  • Performance status - GOG 0-1 (for patients who received 2 prior treatment regimens)
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No known bleeding diathesis
  • Bilirubin ≤ 1.5 times ULN
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No uncontrolled hypertension
  • Able to take oral medication
  • No bowel obstruction or persistent vomiting
  • No requirement for parenteral feedings
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study participation
  • No sensory or motor neuropathy > grade 1
  • No active or ongoing infection requiring antibiotics
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib
  • No serious chronic skin conditions (i.e., psoriasis or dermatitis) that would preclude study participation
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • At least 3 weeks since prior immunologic agents for the malignancy
  • More than 4 weeks since prior mouse antibodies (for patients with evaluable disease only)
  • No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF])
  • No concurrent prophylactic thrombopoietic agents except in the case of recurrent grade 4 thrombocytopenia
  • No other concurrent biological agents for the primary tumor
  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior non-cytotoxic chemotherapy for persistent or recurrent disease
  • No concurrent chemotherapy for the primary tumor
  • At least 1 week since prior hormonal therapy for the malignancy
  • No concurrent hormonal therapy for the primary tumor

    • Concurrent hormone replacement therapy allowed
  • More than 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to > 25% of marrow-bearing areas
  • No concurrent radiotherapy
  • More than 4 weeks since prior surgery involving the peritoneum or pleura (for patients with evaluable disease only)
  • Recovered from prior surgery
  • At least 3 weeks since other prior therapy for the malignancy
  • No more than 1 additional prior cytotoxic regimen for persistent or recurrent disease
  • No prior sorafenib
  • No prior anticancer treatment that would preclude study participation
  • No concurrent therapeutic oral anticoagulation therapy (i.e., warfarin)

    • Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for central venous access devices allowed provided INR is < 1.5
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or commercial agents or therapies for the malignancy
  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: NCT00093626

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Investigators
Principal Investigator: Daniela Matei Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00093626     History of Changes
Other Study ID Numbers: NCI-2012-02624, NCI-2012-02624, CDR0000389246, GOG-0170F, GOG-0170F, U10CA027469
Study First Received: October 6, 2004
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
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
Sorafenib
Niacinamide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on October 01, 2014