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
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