Clinical trial NCT00113373 (phase 2, status: completed)
Conditions: primary peritoneal cavity cancer, recurrent ovarian epithelial cancer
ICD codes: C30.0, Z12.81, D14.0, C14.8, D37.09, Z86.003, Z85.818, H18.523, H18.521, H18.522, H18.529
Drugs: lapatinib ditosylate
SMILES: CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed persistent or recurrent ovarian epithelial or primary
             peritoneal cancer

          -  Measurable disease

               -  At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
                  OR ≥ 10 mm by spiral CT scan

               -  Presence of ≥ 1 target lesion

                    -  Tumors within a previously irradiated field are not considered target
                       lesions unless evidence of progression is documented or proven by biopsy 3
                       months after completion of radiotherapy

          -  Disease progression during OR persistent disease after 1 prior platinum-based
             chemotherapy regimen* for primary disease containing carboplatin, cisplatin, or
             another organoplatinum compound

               -  Initial treatment may have included high-dose therapy, consolidation therapy, or
                  extended therapy administered after surgical or non-surgical assessment

               -  Treatment-free interval after platinum-based chemotherapy < 12 months

          -  Tumor accessible by guided core needle or fine needle biopsy

          -  Ineligible for any higher priority Gynecologic Oncology Group (GOG) protocols (i.e.,
             any active phase III protocol for the same patient population)

          -  Performance status - GOG 0-2 (patients who have received 1 prior treatment regimen)

          -  Performance status - GOG 0-1 (patients who have received 2 prior treatment regimens)

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Serum Glutamate Oxaloacetate Transaminase (SGOT) ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Creatinine ≤ 1.5 times ULN

          -  Ejection fraction normal by echocardiogram or MUGA

          -  No GI disease resulting in an inability to take oral medication

          -  No malabsorption syndrome

          -  No requirement for IV alimentation

          -  No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 1 month after
             completion of study treatment

          -  No active infection requiring antibiotics

          -  No sensory or motor neuropathy > grade 1

          -  No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

          -  No history of allergic reaction attributed to compounds of similar chemical or
             biological composition to lapatinib

          -  At least 4 weeks since prior immunologic agents for the malignancy

          -  No prior trastuzumab (Herceptin®)or cetuximab

          -  See Disease Characteristics

          -  Recovered from prior chemotherapy

          -  At least 6 weeks since prior nitrosoureas or mitomycin for the malignancy

          -  No prior non-cytotoxic chemotherapy for recurrent or persistent disease

          -  At least 2 weeks since prior and no concurrent dexamethasone or dexamethasone
             equivalent dose > 1.5 mg/day

          -  At least 1 week since prior hormonal therapy for the malignancy

          -  Concurrent hormone replacement therapy allowed

          -  See Disease Characteristics

          -  Recovered from prior radiotherapy

          -  No prior radiotherapy to > 25% of marrow-bearing areas

          -  See Disease Characteristics

          -  Recovered from prior surgery

          -  No prior surgical procedure affecting gastrointestinal (GI) absorption

          -  At least 4 weeks since other prior therapy for the malignancy

          -  At least 6 months since prior and no concurrent amiodarone

          -  At least 1 week since other prior and no concurrent CYP3A4 inhibitors

          -  At least 2 weeks since prior and no concurrent CYP3A4 inducers

          -  At least 1 week since prior and no concurrent H2 inhibitors or proton pump inhibitors

               -  Concurrent antacids allowed provided they are not administered within 1 hour
                  before and 1 hour after study drug administration

          -  No prior cancer treatment that would preclude study treatment

          -  No prior lapatinib

          -  No other prior target-specific therapy directed to the HER family (e.g., gefitinib or
             erlotinib)

          -  No concurrent herbal medications

          -  No concurrent combination antiretroviral therapy for HIV-positive patients