Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Phase III Study of Erlotinib Versus Observation in Patients With no Evidence of Disease Progression After First Line, Platinum-Based Chemotherapy For High-Risk Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Brief Summary: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sometimes after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether erlotinib is more effective than observation after first-line chemotherapy in treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to observation in treating patients who have undergone first-line chemotherapy for ovarian cancer, peritoneal cancer, or fallopian tube cancer.


Options:
A: Inclusion Criteria:

* Locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
* Received at least one prior platinum based chemotherapy regimen
* Platinum-resistant or refractory
* Eligible for weekly paclitaxel
* Adequate liver and kidney function
* 18 years of age or above

Exclusion Criteria:

* Evidence of any other active malignancy
* History of severe allergic reactions to paclitaxel or other drugs formulated in Cremophor®EL
B: DISEASE CHARACTERISTICS:

* Histologically proven stage IIIC or IV ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma

  * If biopsy is not available, evidence of adenocarcinoma by fine needle aspiration allowed if all of the following are true:

    * Presence of pelvic ovarian mass
    * Omental cake or other metastasis larger than 2 cm in the upper abdomen and/or regional lymph node metastasis
    * CA 125/carcinoembryonic antigen ratio greater than 25 (if ratio less than 25, barium enema or colonoscopy AND gastroscopy or radiological examination of the stomach must be negative for primary tumor)
    * Normal mammography (if CA 125/carcinoembryonic antigen ratio less than 25)
* Tumor greater than 2 cm, excluding ovaries, on laparoscopy or CT scan
* No brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* WHO 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin less than 1.25 times upper limit of normal (ULN)

Renal:

* Creatinine less than 1.25 times ULN

Other:

* No other serious disabling diseases contraindicating primary cytoreductive surgery or primary platin-based chemotherapy
* No other prior primary malignancies except carcinoma in situ of the cervix or basal cell carcinoma of the skin
* No psychological, familial, sociological, or geographical condition potentially preventing protocol compliance or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* No other prior procedures except diagnostic biopsy by laparotomy or laparoscopy
C: Inclusion Criteria:

* Signed written informed consent.
* Age \>= 18 years old.
* Life expectancy of at least 12 weeks.
* Have histologically confirmed ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancer.
* Have ErbB2-positive cancer as determined by Fluorescence In Situ Hybridization (FISH) assay.
* Have documented tumor progression after receiving all standard/approved chemotherapies per National Comprehensive Cancer Network (NCCN) guidelines (V1) for their specific cancer and no approved therapy exists.
* Have one or more tumors measurable by medical imaging and assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Have archived tumor tissue available for biomarker analysis.
* Have a negative serum pregnancy test if female of childbearing potential.
* Any chemotherapy, major surgery, or irradiation must have been completed at least 3 weeks prior to receiving study drug (6 weeks for mitomycin-C or nitrosourea) and subject must have recovered from all toxicities incurred as a result of previous therapy.
* Have a gastrointestinal tract intact enough to swallow and assure absorption of the drug.
* Women of childbearing potential must have a negative serum pregnancy test at screening and must use an approved contraceptive method, if appropriate (for example, intrauterine device, birth control pills, or barrier device) beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product. Males able to father a child must practice adequate methods of birth control or practice complete abstinence from intercourse from the first dose of investigational treatment until one week after the final dose of investigational treatment.
* Have a cardiac ejection fraction within institutional range of normal as measured by either echocardiogram or multigated acquisition scans. The same method of cardiac evaluation must be used consistently throughout the study.
* Subjects must have adequate organ function:

Hematologic:

absolute neutrophil count \>1.5 x 109/L hemoglobin \>9 g/dL platelets \>75 x 109/L

Hepatic:

albumin \>2.5 g/dL serum bilirubin \<1.25 x upper limit of normal aspartate aminotransferase/alanine aminotransferase \<3 x ULN if no documented liver metastases aspartate aminotransferase/alanine aminotransferase \<5 x ULN with documented liver metastases

Renal:

serum creatinine \<2.0 mg/dL

* OR - calculated creatinine clearance1 \>40 mL/min

Exclusion Criteria:

* Have New York Heart Association Class III or IV, cardiac disease, myocardial infarction within past 6 months, unstable arrhythmia or evidence of ischemia on electrocardiogram.
* Subjects who have had chemotherapy or radiotherapy within 3 weeks prior to entering the study or who have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.
* Concurrent treatment with an investigational agent or participation in another treatment clinical trial.
* Prior lapatinib therapy.
* ECOG Performance Status 2 or greater.
* Subjects receiving concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy (including an ErbB1 and/or ErbB2 inhibitor), or hormonal therapy for treatment of their cancer. Concurrent treatment with bisphosphonates is allowed.
* History of allergic reactions attributed to compounds of similar chemical composition (quinazolines) to lapatinib.
* Concurrent treatment with prohibited medications.
* Malabsorption syndrome, resection of the small bowel or active, uncontrolled ulcerative colitis.
* Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety.
* Uncontrolled infection.
* Pregnant or lactating females.
D: 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

Answer: D