Please select the eligibility criteria that correspond to the clinical trial below.
Title: Addition of Vandetanib to Standard Therapy (Pegliposomal Doxorubicin) in Patients With Recurrent Ovarian Cancer. A Multicentre Phase I / Randomized Phase II Study
Brief Summary: This multi-centre, non-randomized open phase I/randomized phase II study will be conducted in 70 patients (10 in phase I, 60 in phase II) with platinum-refractory recurrent epithelial cancer of the ovary, fallopian tube or peritoneum. A total of approximately 5 national centers will participate in phase I of the study. If the starting criteria for phase II of the study are met at the end of phase I, a total of approximately 20 national centers will participate in phase II of the study.


Options:
A: Inclusion Criteria:

* Histopathologically documented invasive epithelial ovarian carcinoma, cancer of the fallopian tube or the peritoneum refractory to platinum-based chemotherapy or with partially platinum sensitive disease.
* Planned therapy with pegylated liposomal doxorubicin 50 mg/m² for recurrent platinum-refractory ovarian cancer.
* Patients with a progression-free-interval of 6 to 12 months after platinum-based chemotherapy are only eligible if a further course of platinum-based combination chemotherapy is not possible as judged by the investigator(s).
* Patients must have received at least one previous platinum- and taxane-based chemotherapy regimen.

Exclusion Criteria:

* Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
* Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes or induce CYP3A4 function
* Treatment with mouse-antibodies in patients with evaluable disease and CA-125 progressive disease in the last 3 months. These patients are only eligible in case of measurable disease according to RECIST or cytological/histological proven relapse
* More than two prior lines of chemotherapy.
* Any chemotherapy or other systemic anti-cancer therapy within four weeks prior to randomization.
* Radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy
B: 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
C: 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
D: 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.

Answer: A