Clinical trial NCT00093626 (phase 2, status: completed)
Conditions: primary peritoneal carcinoma, recurrent ovarian carcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: sorafenib tosylate
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility 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