Clinical trial NCT00086892 (phase 2, status: completed)
Conditions: ovarian cancer, primary peritoneal cavity cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C30.0, Z12.81, D14.0, C14.8, D37.09, Z86.003, Z85.818
Drugs: carboplatin
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed ovarian epithelial or primary peritoneal cancer

               -  Recurrent disease

          -  Measurable disease

               -  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

               -  Target lesion not within previously irradiated field

          -  Received 1 prior platinum-based chemotherapy regimen for primary disease containing
             carboplatin, cisplatin, or other organoplatinum compound

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

               -  Patients who had not received prior paclitaxel therapy may have received a second
                  regimen that included paclitaxel

          -  Platinum-sensitive disease

               -  Treatment-free interval without clinical evidence of progressive disease for more
                  than 6 months after response to a prior platinum-based regimen

               -  If there is another concurrently active GOG-0146 series protocol
                  (non-platinum-based therapy), must have had a treatment-free interval of more
                  than 12 months unless ineligible for the other protocol* NOTE: *Applies whether
                  or not both protocols are available at the same participating center

          -  Must have available tissue block or unstained sections from primary tumor, interval
             debulking, or secondary debulking

          -  Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG
             protocol for the same patient population)

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  GOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

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

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

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

          -  SGOT ≤ 2.5 times ULN

          -  Alkaline phosphatase ≤ 2.5 times ULN

        Renal

          -  Creatinine ≤ 1.5 times ULN

        Cardiovascular

          -  No uncontrolled hypertension

          -  No unstable angina

          -  No congestive heart failure

          -  No uncontrolled arrhythmias within the past 6 months

          -  No other significant cardiac disease

        Neurologic

          -  No uncontrolled seizure disorder

          -  No active neurological disease

          -  No neuropathy > grade 1

        Other

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

          -  No active infection requiring antibiotics

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior anti-epidermal growth factor receptor (EGFR) antibody therapy

          -  No prior chimerized or murine monoclonal antibody therapy

          -  At least 3 weeks since prior biologic or immunologic therapy for the malignancy

        Chemotherapy

          -  See Disease Characteristics

          -  Recovered from prior chemotherapy

          -  No prior cytotoxic chemotherapy for recurrent disease, including retreatment with
             initial chemotherapy regimens

        Endocrine therapy

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

          -  Concurrent hormone replacement therapy allowed

        Radiotherapy

          -  See Disease Characteristics

          -  Recovered from prior radiotherapy

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

        Surgery

          -  More than 30 days since prior major surgery and recovered

               -  Diagnostic biopsy not considered major surgery

        Other

          -  At least 3 weeks since other prior therapy for the malignancy

          -  No prior tyrosine kinase inhibitors that target the EGFR pathway

          -  No prior cancer treatment that would preclude study treatment

          -  No other concurrent investigational agents