NCCTG-N0871 (Cancer of Unknown Primary (CUP)) | A Phase II Study of Carboplatin (CBDCA), Paclitaxel (TAXOL), and Everolimus (RAD001) in previously Untreated Patients with Measurable Disease with Cancer of Unknown Primary (CUP) (1750)-
Eligibility: click to view information
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Metastatic adenocarcinoma
Poorly differentiated non-small cell carcinoma
Poorly differentiated squamous cell carcinoma
Patients with biopsy proven TTF-1 positive tumor who do not have clinical evidence for either lung or thyroid cancer (e.g., a dominant lung mass) are still eligible
Adequate FFPE tissue samples available
Measurable disease defined as = 1 lesion whose longest diameter can be accurately measured as = 2.0 cm by conventional techniques OR as = 1.0 cm to = 2 cm by spiral CT scan
Disease that has received prior radiotherapy for palliative reasons not considered measurable disease
No untreated brain metastases
Patients with treated, stable brain metastases for = 12 weeks prior to study entry allowed
PATIENT CHARACTERISTICS:
ECOG performance status of 0-2
ANC = 1,500/mm^3
Platelet count = 100,000/mm^3
Hemoglobin = 9.0 g/dL
Total bilirubin normal (= 2 times upper limit of normal [ULN] in presence of liver metastasis)
AST = 2.5 times ULN (= 5 times ULN in presence of liver metastasis)
Creatinine = 1.25 times ULN OR creatinine clearance = 60 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must agree to use effective contraception
No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
No immunocompromised patients including patients known to be HIV positive
No uncontrolled intercurrent illness including, but not limited to, the following conditions:
Ongoing or active infection (acute or chronic)
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Severely impaired lung function
Uncontrolled diabetes as defined by fasting serum glucose > 1.5 times ULN
Liver disease (e.g., cirrhosis, chronic active hepatitis, or chronic persistent hepatitis)
Psychiatric illness and/or social situations that would limit compliance with study requirements
More than 5 years since diagnosis of other malignancy except for non-melanotic skin cancer or carcinoma in situ of the cervix
No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
No active bleeding diathesis
No known HIV positivity
No innoculation with live attenuated vaccines = 2 weeks prior to registration
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Concurrent bisphosphonates allowed
No prior chemotherapy for this cancer
No prior radiotherapy to > 25% bone marrow
Prior radiotherapy for palliative reasons for this cancer allowed
No investigational agent within the past 4 weeks that would be considered treatment for the primary neoplasm
No concurrent chronic systemic treatment with corticosteroids or another immunosuppressive agent
Topical or inhaled corticosteroids allowed
No concurrent enzyme-inducing anti-convulsants or other strong inducers or strong inhibitors of CYP3A4 (e.g., carbamazepine, phenytoin, phenobarbital, primidone, rifabutin, rifampin, or St. John wort)
No concurrent warfarin (coumadin) except for low-molecular weight heparin use
No concurrent grapefruit, Seville oranges, or star fruit or their juices
No other concurrent investigational therapy
No other concurrent anticancer agents
- Consent Forms: N0871 Consent
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