Clinical trial NCT00126542 (phase 2, status: completed)
Conditions: fallopian tube cancer, primary peritoneal cavity cancer, recurrent ovarian epithelial cancer, stage iv ovarian epithelial cancer
ICD codes: C57.00, C57.01, C57.02, C30.0, Z12.81, D14.0, C14.8, D37.09, Z86.003, Z85.818, H18.523, H18.521, H18.522, H18.529, H18.523, H18.521, H18.522, H18.529
Drugs: erlotinib hydrochloride
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or
             primary peritoneal cavity cancer

               -  Recurrent or metastatic disease

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable indicator lesion ≥ 20
             mm by conventional techniques OR ≥ 10 mm by spiral CT scan

          -  Must have received a platinum-containing chemotherapy regimen for primary disease

               -  Re-treatment with a platinum-based regimen required for patients who achieved a
                  clinical complete response (CR) to primary therapy and then had a treatment-free
                  interval > 12 months (i.e., platinum-sensitive) unless the patient developed a
                  hypersensitivity to platinum

                    -  Patients with a treatment-free interval < 12 months do not require prior
                       chemotherapy for recurrent disease

          -  No evidence of CNS disease, including primary brain tumors or brain metastasis

          -  Performance status - ECOG 0-2

          -  More than 3 months

          -  WBC ≥ 3,000/mm^3

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

          -  Platelet count ≥ 100,000/mm^3

          -  No history of bleeding diathesis

          -  SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver
             metastasis)

          -  Bilirubin normal

          -  INR ≤ 1.5 (3 if receiving warfarin)

          -  No history of esophageal varices

          -  Creatinine ≤ 1.5 mg/dL

          -  Creatinine clearance ≥ 60 mL/min

          -  Urine protein < 1+

          -  Urine protein < 1,000 mg on 24-hour urine collection

          -  Urine protein:creatinine ratio < 1.0

          -  No arterial thromboembolic event within the past 6 months, including any of the
             following:

               -  Transient ischemic attack

               -  Cerebrovascular accident

               -  Unstable angina pectoris

               -  Myocardial infarction

          -  No clinically significant peripheral artery disease

          -  No uncontrolled hypertension

          -  No New York Heart Association grade II-IV congestive heart failure

          -  No serious cardiac arrhythmia requiring medication

          -  No peripheral vascular disease ≥ grade 2

          -  Not pregnant

          -  No nursing during and for ≥ 3 months after study participation

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 3 months after
             study participation

          -  No history of allergic reaction attributed to compounds of similar chemical or
             biological composition to study drugs (e.g., Chinese hamster ovary cell products or
             recombinant humanized antibodies)

          -  No serious or non-healing wound, ulcer, or bone fracture

          -  No active infection requiring parenteral antibiotics

          -  No other active malignancy within the past 5 years except nonmelanoma skin cancer or
             carcinoma in situ of the cervix

          -  No gastrointestinal tract disease resulting in an inability to take oral medication

          -  No significant traumatic injury within the past 28 days

          -  No known HIV positivity

          -  No prior bevacizumab

          -  See Disease Characteristics

          -  No more than 2 prior cytotoxic chemotherapy regimens for recurrent or refractory
             disease (i.e., failed to achieve a clinical CR after primary therapy)

          -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

          -  More than 4 weeks since prior radiotherapy

          -  No prior radiotherapy to any indicator lesion unless disease has progressed since
             completion of radiotherapy

          -  More than 4 weeks since prior major surgical procedure or open biopsy

          -  More than 1 week since prior core biopsy

          -  No prior surgery affecting absorption

          -  No concurrent major surgery

          -  Recovered from prior therapy

          -  No prior vascular endothelial growth factor (VEGF) or an epidermal growth factor
             receptor (EGFR) directed therapy

          -  No prior erlotinib

          -  At least 30 days since prior investigational drugs

          -  More than 1 month since prior thrombolytic agents

          -  Concurrent warfarin allowed provided the following criteria are met:

               -  Patient is on a therapeutic stable dose of warfarin

               -  INR ≤ 3

               -  No active bleeding or pathological condition that would confer a high risk of
                  bleeding (e.g., tumor invading adjacent organs or major blood vessels or varices
                  that are likely to bleed)

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy