Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01155258
Eligibility Criteria:
Inclusion
* Patients with histologically confirmed metastatic or unresectable solid tumors for which standard curative measures do not exist or are no longer effective; histology will be limited to those tumors for which temsirolimus or vinorelbine have reported clinical activity: lung, breast, ovary, cervix, prostate, uterus, renal, bladder and neuroendocrine tumors
* SWOG performance status of 0-2
* Projected life expectancy of at least 3 months
* Provision of informed consent prior to any study-related procedures
* Negative pregnancy test for women of childbearing potential
* Female patients must not be pregnant due to the potential mutagenicity and teratogenicity of this treatment; a pregnancy test must be administered 7 days prior to administration of therapy to women of childbearing potential; patients must agree to use some form of contraception while on this study at initiation and for the duration of participation in the study; sexually active males must also use a reliable and appropriate method of contraception; post-menopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential
* Patients must have recovered from acute toxicities from previous surgery, chemotherapy or radiation therapy
* ANC \>= 1500/mm\^3
* Platelet count \>= 100,000 cells/mm\^3
* Hemoglobin \>= 9.0g/dL
* Serum creatinine =\< 1.5 mg/dl
* Hepatic function: Patients must have adequate liver functions: AST or ALT =\< 2.5 X upper limit of normal (ULN), alkaline phosphatase =\< 2.5 X upper limit of normal; in patients with bone metastasis and no evidence of liver metastasis and bilirubin =\< upper limit of normal an alkaline phosphatase =\< 5 ULN will be allowed
* Serum Bilirubin =\< 1.0 mg/dL
* Peripheral neuropathy grade 0-1
* No other concomitant therapy directed at the cancer is allowed
Exclusion
* Prior therapy with vinorelbine or an mTor inhibitor
* Receipt of any investigational agents within 30 days prior to commencing study treatment
* Last dose of prior chemotherapy discontinued less than 4 weeks before the start of study therapy
* Last radiation therapy within the last 4 weeks before the start of study therapy, except palliative radiotherapy
* Any unresolved toxicity greater than CTC grade 1 from previous anticancer therapy, excluding alopecia
* CTC Grade 1 or greater neuropathy (motor or sensory) at study entry
* Hematologic function with absolute neutrophils =\< 1500/mm\^3 and/or platelets \< 100,000/mm\^3
* Hepatic function with serum bilirubin greater than the upper institutional limits of normal, ALT and AST \> 2.5 times the upper institutional limits of normal
* Concurrent use of strong inhibitors of CYP3A4: ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine and voriconazole
* CYP3A4 inducers should be avoided or used with caution; the use of these agents is discouraged: rifabutin, rifampicin, rifapentine, carbamazepine, Phenobarbital, phenytoin and St. John's wart
* Ongoing long term use of steroids for chronic conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01155258
Study Brief:
Protocol Section:
NCT01155258