Clinical trial NCT00263822 (phase 3, status: completed)
Conditions: fallopian tube cancer, ovarian cancer, primary peritoneal cavity cancer
ICD codes: C57.00, C57.01, C57.02, 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: erlotinib hydrochloride
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube
             cancer meeting 1 of the following criteria:

               -  High-risk stage I disease, as defined by grade 3, aneuploid grade 1 or 2, or
                  clear cell disease

               -  Stage II, III, or IV disease

          -  Completed first-line therapy within the past 6 weeks

               -  Received a platinum derivative (carboplatin or cisplatin) alone or in combination
                  with other agents for 6-9 courses

               -  Must have achieved complete response/no evidence of disease, partial response, or
                  stabilization of disease after therapy

          -  No adenocarcinoma of unknown origin

          -  No known brain metastases or leptomeningeal disease

        PATIENT CHARACTERISTICS:

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Platelet count ≥ 100,000/mm^3

          -  WBC ≥ 2,000/mm^3

        Hepatic

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in patients with
             known liver metastases)

          -  Bilirubin ≤ 1.5 times ULN

          -  Alkaline phosphatase ≤ 5 times ULN except in patients with known bone metastases

          -  PT and PTT ≤ 1.5 times ULN

        Renal

          -  Creatinine ≤ 2 times ULN

        Cardiovascular

          -  No myocardial infarction within past 6 months

          -  No second- or third-degree heart block without pacemaker

        Gastrointestinal

          -  No active peptic ulcer disease

          -  No gastrointestinal tract disease that would interfere with ability to take oral
             medications, affect absorption, or require parenteral nutrition

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

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No significant dermatologic disease

          -  No inflammatory changes to the surface of the eye

          -  No history of allergic reaction to compounds of similar chemical composition as
             erlotinib

          -  No other significant medical condition or neurologic or psychiatric disorder

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or cone-biopsied carcinoma in situ of the cervix

          -  No psychiatric illness or familial, geographic, or social situation that would
             preclude study compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior therapy targeting epidermal growth factor receptor

          -  No concurrent immunotherapy

        Chemotherapy

          -  See Disease Characteristics

          -  See Surgery

          -  No concurrent chemotherapy

        Endocrine therapy

          -  No concurrent hormonal therapy

        Radiotherapy

          -  No prior radiotherapy unless completed more than 5 years ago AND outside the
             abdomen/pelvis

        Surgery

          -  Interval debulking surgery after 3 courses of chemotherapy and second-look surgery at
             the end of chemotherapy allowed as per study EORTC-55971/NCIC OV13/Chorus

        Other

          -  No other prior or concurrent investigational agents

          -  No other concurrent anticancer treatment

          -  Concurrent participation in study EORTC-55971/NCIC-OV13/Chorus allowed