Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II Trial Of IM862 Combined With Paclitaxel And Carboplatin In Newly Diagnosed Advanced Epithelial Ovarian Or Primary Peritoneal Carcinoma Followed By IM862 Consolidation Therapy
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Combining chemotherapy and IM-862 may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer.


Options:
A: DISEASE CHARACTERISTICS: Histologically confirmed stage III ovarian epithelial cancer or primary peritoneal carcinoma of one of the following cell types: Serous adenocarcinoma Mucinous adenocarcinoma Clear-cell adenocarcinoma Endometrioid Adenocarcinoma (not otherwise specified) Undifferentiated carcinoma Transitional cell Malignant Brenner's tumor Mixed epithelial carcinoma No borderline tumor (tumor of low malignant potential) Underwent prior standard initial cytoreductive surgery within the past 6 weeks Optimally resected disease with no residual site of disease more than 1 cm in greatest dimension Removal of all disease extending beyond the reproductive tract Total hysterectomy and bilateral salpingo-oopherectomy at cytoreductive surgery or in the past

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN SGOT no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast No other major systemic medical illness that would preclude survival No poor general condition or medical, social, or psychosocial factors that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for current malignancy At least 5 years since prior gene therapy At least 1 year since prior interleukin-2 (IL-2) At least 1 year since prior sargramostim (GM-CSF) Concurrent filgrastim (G-CSF) allowed No concurrent gene therapy No concurrent GM-CSF No concurrent IL-2 No other concurrent angiogenesis inhibitors (e.g., thalidomide, cyclooxygenase-2 inhibitors (e.g., rofecoxib or celecoxib), interferon products, or angiotensin-converting enzyme inhibitors) Chemotherapy: At least 5 years since prior anticancer chemotherapy No prior chemotherapy for current malignancy No other concurrent chemotherapy Endocrine therapy: No prior endocrine therapy for current malignancy At least 1 year since prior tamoxifen No concurrent tamoxifen Radiotherapy: No prior radiotherapy for current malignancy Surgery: See Disease Characteristics Other: At least 1 year since prior experimental or investigational medications No other concurrent experimental or investigational medications
B: Inclusion Criteria:

1. Female, aged ≥ 18 years
2. Histologically and/or cytologically proven epithelial ovarian, epithelial fallopian tube cancer or primary peritoneal cancer
3. Progression free interval between six and twelve (6-12) months (calculated from the first day of the last cycle of the last platinum-based chemotherapy until the date of progression confirmation through radiologic imagery). Patients may have received up to two platinum-based chemotherapy lines, of which at least one must have contained a taxane
4. Measurable or evaluable disease confirmed by radiological imaging, such as magnetic resonance imaging (MRI), computed tomography (CT) scan, or PET/CT scan at study entry (CA-125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression) or histological proven recurrent ovarian cancer even in the absence of postoperatively measurable or evaluable lesions.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
6. Estimated life expectancy ≥ 12 weeks
7. Patients must be accessible for treatment and follow-up
8. Adequate organ function within 14 days prior to first cycle as evidenced
9. Patients must be able to receive dexamethasone or its equivalent, which is required if randomly assigned to treatment with trabectedin plus PLD
10. Informed consent of the patient

Exclusion Criteria:

1. Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)
2. Patients who did not respond to last platinum-based therapy or in whom last relapse occurred \< 6 months or \> 12 months from the last dose of platinum
3. Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases
4. Pre-existing grade \> 1 motor or sensory neuropathy according to the National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.0
5. Myocardial infarct within six months before enrolment, New York Association (NYHA) Class II or worse heart failure (Appendix 1. The New York Heart Association), uncontrolled angina, severe uncontrolled ventricular arrythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
6. History of liver disease
7. Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
8. Breastfeeding women and women of child bearing potential must use effective contraception during treatment and 3 months thereafter, which may include prescription contraceptives (oral, injection, or patch), intrauterine device, double-barrier method or male partner sterilization (not applicable to patients that are surgically sterile)
9. Prior exposure to trabectedin
10. Prior resistance to anthracyclines or PLD defined as a progression during anthracycline-based chemotherapy or a recurrence within 6 months from its ending
11. Prior severe PLD related toxicity
12. Prior exposure to cumulative doses of doxorubicin \>400mg/m2 or epirubicin \>720mg/m2
13. Treatment with any investigational product within 30 days prior to inclusion in the study
C: Inclusion Criteria:

1. Histologically confirmed, stage III or IV epithelial ovarian carcinoma
2. No previous treatment with chemotherapy or radiation therapy
3. All patients must have undergone cytoreductive surgery, with the

   following results:
   1. No residual tumor nodule \> 3cm
   2. No residual tumor involvement of the bowel (ie. invasion into bowel

      wall)
   3. No residual intestinal obstruction
4. Measurable or evaluable disease. Patients with elevated CA-125 levels

   and/or evaluable disease per RECIST criteria are eligible.
5. ECOG performance status 0 or 1.
6. ANC ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9.0 g/dL.
7. Total bilirubin ≤ 1.5 x upper limits of normal (ULN), ALT and AST ≤ 2.5 x

   ULN (≤ 5 x ULN for patients with liver metastases)
8. Serum creatinine _ 1.5 x ULN
9. INR \< 1.5 or a PT/PTT within normal limits. Patients receiving anticoagulation

   treatment with an agent such as warfarin or heparin may be

   allowed to participate. For patients on warfarin, the INR may be \> 1.5,

   and should be measured prior to initiation of sorafenib and monitored at

   least weekly until INR is stable in the desired therapeutic range.
10. Women of childbearing potential must have a negative serum pregnancy

    test performed within 7 days prior to start of treatment.
11. Patients must be able to understand the nature of this study and give

written informed consent.

Exclusion Criteria:

1. Age \< 18 years
2. Active cardiac disease, including: A) congestive heart failure \> class II

   NYHA , B) unstable angina or onset of angina within last 3 months, C) myocardial infarction within 6 months
3. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
4. Patients with CNS metastases. Patients with neurological symptoms

   must undergo a CT scan/MRI of the brain to exclude brain metastasis.
5. Uncontrolled hypertension defined as systolic blood pressure \> 150mmHg or diastolic pressure \> 90mmHg, despite optimal medical management
6. Known HIV, chronic hepatitis B or chronic hepatitis C infections
7. Women who are pregnant or lactating. Women of childbearing potential

   must agree to use adequate contraception from time of study entry until

   at least 3 months after the last administration of study drug.
8. Active clinically serious infection (\> grade 2)
9. Thrombotic or embolic events such as cerebral vascular accident

   including transient ischemic attacks within the last 6 months.
10. Pulmonary hemorrhage/bleeding event ≥ grade 2 within 4 weeks of

    starting treatment.
11. Any other hemorrhage/bleeding event ≥ grade 3 within 4 weeks of

    starting treatment
12. Serious non-healing wound, ulcer, or bone fracture
13. Evidence of history of bleeding diathesis or coagulopathy
14. Major surgery, open biopsy, or significant traumatic injury within 4 weeks

    of starting treatment.
15. Any condition that impairs the ability to swallow whole pills
16. Patients with any type of malabsorption
17. Known or suspected allergy to any of the agents used in this treatment
18. Use of St. John's Wort or rifampin
D: Inclusion Criteria:

* Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
* Histologically confirmed and documented ovarian cancer with malignant ascites.
* ECOG(Eastern Cooperative Oncology Group, ECOG) PS 0-2.
* Life expectancy of \>3 months.
* No serious inadequate bone marrow function, liver and renal function or significant cardiovascular disease.

Exclusion Criteria:

* Known hypersensitivity to any of the study drugs or excipients.
* Any current anti-cancer therapy.
* No evidence of ascites.
* Key organ dysfunction.
* Significant cardiovascular disease (e.g. congestive heart failure (CHF), uncontrolled cardiac arrhythmia, angina, heart valve disease, myocardial infarction and refractory hypertension need to be long time controlled by medicine).
* Non-healing wound, ulcer or bone fracture.
* Uncontrolled psychiatric history.

Answer: A