Please select the eligibility criteria that correspond to the clinical trial below.
Title: Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial
Brief Summary: The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.


Options:
A: Inclusion Criteria:

* ≥ 18 years of age
* high risk uterine LMS, FIGO stage I or II
* pathology review of LMS high grade and /or mitotic rate greater than or equal to 5 mitoses/10 hpf
* no longer than 12 weeks from surgical resection of cancer
* no evidence of residual disease
* ECOG 0 or 1
* ANC ≥ 1,500, hemoglobin ≥ 8.0, platelets ≥100,000
* creatinine ≤ 1.5 x institutional upper limits of normal
* adequate liver function
* neuropathy (sensory and motor) ≤ CTC grade 1
* negative pregnancy test
* signed consent

Exclusion Criteria:

* patients with other invasive malignancies
* prior therapy with gemcitabine or docetaxel or doxorubicin
* hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* women who are breast feeding
* cardiac ejection fraction \<50%
* prior pelvic irradiation
* treatment with hormone replacement or anti-hormonal agents or other cytotoxic agents
B: DISEASE CHARACTERISTICS:

* Histologically proven soft tissue sarcoma that is amenable to definitive surgery no more than 8 weeks after biopsy or inadequate surgery

  * Eligible subtypes:

    * Alveolar soft part sarcoma
    * Angiosarcoma
    * Fibrosarcoma
    * Leiomyosarcoma
    * Malignant fibrous histiocytoma
    * Liposarcoma (round cell and pleomorphic)
    * Miscellaneous sarcoma (including pelvic mixed mesodermal tumors)
    * Malignant paraganglioma
    * Neurogenic sarcoma
    * Rhabdomyosarcoma
    * Synovial sarcoma
    * Unclassifiable sarcoma
  * Ineligible subtypes:

    * Chondrosarcoma
    * Dermatofibrosarcoma
    * Embryonal rhabdomyosarcoma
    * Ewing's sarcoma
    * Kaposi's sarcoma
    * Liposarcoma (myxoid and well differentiated)
    * Malignant mesothelioma
    * Neuroblastoma
    * Osteosarcoma
* Confirmed high-grade tumor (i.e., Trojani Grade II or III)
* No metastases on staging with chest x-ray and thoracic CT scan
* No regional lymph node involvement
* Locally recurrent disease allowed

  * Interval of 3 months or more between definitive surgery and recurrence

PATIENT CHARACTERISTICS:

Age:

* 16 to 69

Performance status:

* WHO 0-1

Life expectancy:

* Not specified

Hematopoietic:

* WBC greater than 4,000/mm\^3
* Platelet count greater than 120,000/mm\^3
* No bleeding disorders

Hepatic:

* Bilirubin no greater than 1.25 times normal
* No severe hepatic dysfunction

Renal:

* Creatinine less than 1.6 mg/dL OR
* Creatinine clearance greater than 60 mL/min

Cardiovascular:

* No clear history of angina
* No documented myocardial infarction
* No existing cardiac failure

Other:

* No serious infection
* No other malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior systemic chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy to affected area

Surgery:

* See Disease Characteristics
C: DISEASE CHARACTERISTICS:

* Histologically confirmed localized Ewing's sarcoma or peripheral primitive neuroectodermal tumor (PNET) of the bone or soft tissues

  * Diagnostic biopsy of primary tumor within 30 days of study
* Paraspinal or bony skull tumors of extradural origin allowed

  * No intradural soft tissue tumors
* Askin's tumor of the chest wall allowed

  * Chest wall tumors with ipsilateral pleural effusions or ipsilateral pleural-based secondary tumor nodules allowed
  * No contralateral pleural effusions
* No metastatic disease or distant node involvement

  * One pulmonary or pleural nodule greater than 1 cm in diameter OR more than 1 nodule greater than 0.5 cm in diameter are considered pulmonary metastasis
  * Solitary lung nodules of 0.5-1 cm OR multiple nodules of 0.3-0.5 cm allowed unless biopsy positive for tumor
* Light microscopic appearance (hematoxylin and eosin stained) consistent with Ewing's sarcoma or peripheral PNET
* No immunohistochemical or ultrastructural evidence of rhabdomyosarcoma
* No esthesioneuroblastoma
* Clinically or pathologically involved regional lymph nodes allowed
* No CNS involvement

PATIENT CHARACTERISTICS:

Age:

* 50 and under at diagnosis

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 1.5 mg/dL

Renal:

* Creatinine normal for age
* Creatinine clearance or isotope glomerular filtration rate at least 75 mL/min

Cardiovascular:

* Shortening fraction at least 28% by echocardiography OR
* Ejection fraction at least 55% by radionuclide angiogram

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other prior malignancy except skin cancer diagnosed at least 5 years ago and currently in remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior immunotherapy for skin cancer
* No concurrent sargramostim (GM-CSF)
* No concurrent pegfilgrastim

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy

Surgery:

* Prior complete or partial excision of primary tumor allowed
D: Inclusion Criteria:

* Patients with histologically documented and not surgically resectable or metastatic high-grade osteosarcoma which progressed after first or second line treatments for relapsing disease
* Measurable disease as defined by RECIST criteria vs. 1.1 (bone lesions are allowed). Baseline evaluations must be completed within 28 days prior to enrollment
* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1. ECOG PS 2 patients are eligible if the PS 2 depends solely on orthopedic problems
* Estimated life expectancy of at least 3months
* Age≥18 years
* Adequate bone marrow, liver and renal function: Hemoglobin\>9.0g/dl, Absolute neutrophil count\>1,500/mm3, Platelet\>100,000/μl Total bilirubin\<1.5 times the upper limit of normal (ULN), ALT and AST\<2.5xULN (\<5xULN for patients with liver involvement of their cancer), PT-INR/PTT\<1.5xULN, Serum creatinine\<2xULN
* Written informed consent

Exclusion Criteria:

* Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
* Patients with any severe and/or uncontrolled medical conditions such as unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6months, serious uncontrolled cardiac arrhythmia, uncontrolled hyperlipidemia, active or uncontrolled severe infection, cirrhosis, chronic or persistent active hepatitis or severely impaired lung function.
* History of HIV infection and active clinically serious infections (\>grade 2 according to NCI-CTCAE vs. 4.0)
* Symptomatic metastatic brain or meningeal tumors (unless the patient is \>6months from definitive therapy, has a negative imaging study within 4weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
* Patients with seizure disorders requiring medication
* Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7days of the start of treatment. Both men and women must use adequate barrier birth control measures during the course of the trial and 8weeks after last dose of study drug
* Patients with evidence or history of bleeding diathesis
* Patients undergoing renal dialysis
* Patients unable to swallow oral medications
* Uncontrolled diabetes (fasting glucose\>2xULN)
* Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent (except corticosteroids with a daily dosage equivalent to prednisone ≤20mg for adrenal insufficiency). Patients receiving corticosteroids must be on a stable dose for ≥4weeks prior to the first dose of Everolimus. Topical or inhaled corticosteroids are permitted
* Patients with a history of another malignancy within 5years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer skin or other solid tumors curatively treated with no evidence of disease for ≥3years. Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
* Anticancer chemotherapy or immunotherapy during the study or within 4weeks of study entry
* Radiotherapy during study or within 3weeks of start of study drug. (Palliative radiotherapy will be allowed)
* Major surgery within 4weeks of start of study
* Investigational drug therapy outside of this trial during or within 4weeks of study entry
* Prior exposure to the study drugs or their analogues
* Patients with known hypersensitivity to sorafenib, everolimus or other rapamycin analogs, or to its excipients
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* A history of noncompliance to medical regimens or inability or unwillingness to return for scheduled visits

Answer: A