Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cance⦠(NCT01737502) | Clinical Trial Compass
CompletedPhase 1/2
Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer
United States29 participantsStarted 2014-05-14
Plain-language summary
This phase I/II trial studies the side effects and best dose of auranofin when given together with sirolimus and to see how well it works in treating patients with lung cancer that has spread or other places in the body and cannot be cured or controlled by treatment or has come back after a period of time during which the cancer could not be detected. Auranofin and sirolimus may stop or slow the growth of lung cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologic or cytologic confirmation of lung cancer (squamous, ras-mutated adenocarcinoma or small cell lung cancer)
* Patients must have received at least one course of chemotherapy consisting of a platinum doublet and must have no acceptable standard treatment options
* Prior radiation therapy is permitted as long as:
* Recovered from the toxic effects of radiation treatment before study entry, except for alopecia
* Absolute neutrophil count (ANC) \>= 1500 uL
* Platelets (PLT) \>= 100,000 uL
* Hemoglobin (Hgb) \>= 9 g/dL
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) or direct bilirubin =\< ULN
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 3 x ULN or SGOT (AST) and SGPT (ALT) =\< 5 x ULN is acceptable if liver has tumor involvement
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
* Negative serum pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
* Ability to provide informed consent
* Life expectancy \>= 12 weeks
* Willing to return to Mayo Clinic enrolling institution for follow-up
* Willing to provide tissue samples for correlative research purposes
Exclusion Criteria:
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Symptomatic, untrā¦
What they're measuring
1
Number of Phase 1 Patients Experiencing a DLT
Timeframe: 28 days
2
Number Phase 1 Patients Experiencing a Grade 3+ AE