Please select the eligibility criteria that correspond to the clinical trial below.
Title: MITO-11: A Randomized Multicentre Phase II Trial With Pazopanib and Weekly Paclitaxel vs Weekly Paclitaxel in Platinum Resistant or Refractory Ovarian Cancer
Brief Summary: The purpose of this study is to evaluate the safety and activity of adding pazopanib to weekly chemotherapy with paclitaxel for patients with ovarian cancer that is resistant or refractory to treatment with platinum based therapy.


Options:
A: Inclusion Criteria:

1. Pathologically and radiologically confirmed stage IV or postoperative recurrence ovarian cancer.
2. Age of 18-70, Karnofsky score higher than 80.
3. No severe functional damage of major organ, normal liver and kidney function.
4. Peritoneal adhesion. (1) peritoneal adhesions diagnosed by microlaparoscopy or abdominal operations, and classification according to Nair criteria is performed. (1) must be met. (2) Peritoneal adhesion symptoms, intermittent abdominal pain, abdominal distension, nausea and vomiting, hard to pass stools or gas; (3) Peritoneal adhesion signs，abdominal distension, abdominal tenderness, reduced or absent bowel sounds; (4) B ultrasound or CT or MRI show peritoneal adhesion or adhesion-related complications.

Exclusion Criteria:

1. Complete intestinal obstruction and suitable for surgery.
2. Patients known to be allergic to bevacizumab or any of the components of the drug.
3. Other ongoing anti-tumor treatment.
4. Heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure
5. Active wound infection and a history of uncontrolled psychiatric illness.

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B: Inclusion Criteria:

* Cytologic / histologic diagnosis of stage IC-IV ovarian cancer
* Disease progressed during first line chemotherapy or disease relapsed within 6 months after the last platinum treatment
* Disease evaluable by RECIST or Ca 125 GCIG criteria
* No residual peripheral neurotoxicity from previous chemotherapy treatment
* PS 0-1
* Aged at least 18 and not greater than 75 years.
* Life expectancy of at least 3 months
* Able to swallow and retain oral medication
* Written informed consent prior to performance of study specific procedures or assessments
* Ability and willingness to comply with treatment and follow up assessments and procedures

Exclusion Criteria:

· • Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)

* Previous treatment with weekly paclitaxel
* More than 2 previous chemotherapy treatments
* Serious heart disease, including heart failure, atrioventricular block of any degree, serious arrhythmia or history of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, coronary artery by-pass graft surgery, class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
* Hemoglobin \< 9 g/dL, neutrophils \< 1500/mm3, platelets \< 100000/mm3
* Impairment of renal function (patients should have 2 functioning kidneys): creatinine 1.5 times the upper normal limit - UNL; calculated creatinine clearance \< 50 mL/min; urine protein to creatinine ratio \> or = 1: then, a 24-hour urine protein must be assessed and subject must have a 24-hour urine protein value \<1gr to be eligible
* Impairment of liver function (SGOT or SGPT \> or = 2.5 UNL, alkaline phosphatase \> 2.5 ULN, total bilirubin \> 1.5 times the UNL)
* Prothrombin time (PT) or international normalized ratio (INR) or activated partial thromboplastin time (PTT) \> 1.2 times the UNL
* Pregnancy, breast feeding, or inadequate contraception
* Unable to discontinue prohibited medications (see protocol section 6.7)
* Clinically significant gastrointestinal abnormalities which might interfere with oral dosing, including but not limited to malabsorption syndrome, major resection of the stomach or small bowel that could affect drug absorption, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment, signs or symptoms of GI obstruction
* Any unstable or serious concurrent condition
* Prolongation of corrected QT interval (QTc) \>480 ms
* History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
* Macroscopic hematuria
* Major surgery or trauma within 30 days
* Hypertension uncontrolled with adequate therapy (systolic blood pressure (BP) of \> or = 140mmHg, or diastolic BP of \> or = 90mmHg)
* Any ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity
* Present or suspected haemorrhagic syndromes
* Patients' inability to access the centre due to area of residence
C: Inclusion Criteria:

1. Histologically verified epithelial ovarian cancer, primary tubae- or primary peritoneal cancer (Stage I-IV)
2. Carboplatin resistant ovarian cancer previously treated with a maximum of three different cytostatic regimens (single substance or in combination).
3. Age ≥ 18 years.
4. Performance status 0-2.
5. Measurable disease according to CA125 GCIG criteria (Gynaecologic Cancer Intergroup) or RECIST (Response Evaluation Criteria in Solid Tumors) (See appendix I+II)
6. Adequate bonemarrow, liver and kidney function and coagulation parameters (within seven days of start of treatment).
7. ANC ≥ 1.5\*109
8. Thrombocytes ≥ 100\*10\^9/L
9. Haemoglobin (Hb) ≥ 6 mmol/l
10. Se-bilirubin (BR) ≤ 1.5\*ULN (Upper Limit of Normal)
11. Se-transaminase ≤ 2.5\*ULN
12. Se-creatinin ≤ 1.5\*ULN
13. Urin stix for protein \<2+ (If stix shows protein ≥2+ urin must be measured 24 hours where the protein content must be under 1 g.)
14. INR ≤1.5
15. APTT ≤ 1.5\*ULN
16. Signed informed consent form.

Exclusion Criteria:

1. Patients who have received other types of experimental treatment or participated in a clinical study less than 28 days prior to this study.
2. Pregnant or breastfeeding women. A negative pregnancy test is mandatory for fertile women.
3. Fertile women, who do not wish to use safe contraception (e.g., birth control pills, coil, gestagen deposit injection, subdermal implantation, hormonal vagina ring, and transdermal deposit band-aid).
4. Untreated bowel obstruction or massive gastrointestinal tumors verified by CT scan.
5. Other present or previous malignant disease apart from curatively treated non-melanoma skin cancer or other types of cancer with minimal risk of relapse.
6. CNS-metastases.
7. Underlying medical disease not adequately treated (diabetes, cardiovascular disease).
8. Uncontrolled hypertension (persistent BP \> 150/100 despite antihypertensive treatment).
9. Surgery incl. open biopsy less than 4 weeks before expected first dose of Bevacizumab.
10. Patients with non-healing wounds or fractures.
11. Previous cerebrovascular attack (TVA), transient ischaemic attack (TIA) or subarachnoidal bleeding (SAH) within last six months.
12. Thromboembolic or haemorrhagic disease in the anamnesis.
13. Clinically significant cardiovascular disease including Myocardial infarction or unstable angina less than 6 months prior to treatment

    * New York heart Association NYHA class ≥ 2
    * Poorly controlled cardial arrythmia despite medical treatment
    * Peripheral vascular disease, grade 3 or above.
14. Present or previous chronical use of Aspirin (less than 10 days before start of treatment) Aspirin \> 325 mg daily.
15. Present or recent use of full dose oral or parenteral anticoagulant or thrombolytic medicine.
16. Preexisting neuropathy, sensoric or motoric ≥ grade 2.
17. Decreased hearing.
18. Bleeding tumor.
19. Hypersensitivity to the active substance or one or more of the other substances contained in the protocol drugs.
20. Hypersensitivity to products from ovarian cells (CHO) from Chinese hamster or other recombinant or humanized antibodies.
D: Inclusion Criteria:

* Female patients with histologically confirmed advanced ovarian carcinoma, fallopian tube carcinoma or primary peritoneal cancer of serous type with recurrent disease and who responded to 2nd, 3rd or 4th line chemotherapy. Response is defined as either a confirmed decline in CA125 of at least 50% from the pre-treatment value or an Objective Response, i.e. a Partial Response (PR) or Complete Response (CR) according to the RECIST criteria in patients with measurable disease.
* Treatment-free interval of \< 12 months since commencing prior treatment regimen for relapsed ovarian cancer.
* Full recovery from all therapy related toxicities of previous chemotherapy and or radiotherapy or recovery in as much as no further improvement may be expected by the investigator.
* Age \> 18 years.
* Life expectancy of at least 3 months.
* ECOG Performance Score \< 2.
* Adequate hepatic function: total bilirubin 26µmol/L, ALT and/or AST 1.5x upper limit of normal (ULN). INR, Prothrombin time (PT) and partial thromboplastin time (PTT): maximum 50% deviation from normal limits.
* Adequate renal function: serum creatinine 1.5 x ULN.
* Absolute neutrophil count (ANC) \>1.5 x 109l, Platelets \> 100 x 109/l, Haemoglobin \> 9.0 g/dl.
* Written informed consent consistent with ICH-GCP guidelines.
* Minimum time elapsed since last chemotherapy (including hormonal treatment other than Hormone Replacement Therapy \[HRT\]) or immunotherapy and the first administration of BIBF 1120 must be more than 4 but less than 8 weeks.

Exclusion Criteria:

* Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.
* Major injuries and/or surgery within past 4 weeks with incomplete wound healing or bone fracture and planned surgical procedures during the study period.
* Hypersensitivity to BIBF 1120 or the excipients of the study drug.
* Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 9 months, congestive heart failure \> NYHA II).
* History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
* Patients who require full-dose anticoagulation.
* Gastrointestinal disorders or abnormalities that would inhibit absorption of the study drug.
* Brain metastases or leptomeningeal disease.
* Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial.
* Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug.
* Patients unable to comply with the protocol.
* Active alcohol or drug abuse.
* Other documented malignancy with the exception of non-melanomatous skin cancer within the past 5 years.
* Patients who are not clinically sterile.

Answer: B