Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary

Completed · Phase 2

Conditions studied: Carcinoma of Unknown Primary Origin

In brief

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well carboplatin given together with paclitaxel and everolimus works in treating patients with previously untreated cancer of unknown primary.

Key facts

Study ID

NCT00936702

Run by

Alliance for Clinical Trials in Oncology

People needed

46

Starts

2009-09-01

Expected to finish

2013-08-01

Last updated by the study team

2017-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological confirmation of metastatic adenocarcinoma, poorly differentiated non-small cell carcinoma, or poorly differentiated squamous carcinoma
• Adequate FFPE tissue or re-biopsy planned after registration but prior to treatment
• Measurable disease as defined; for patients having only lesions measuring at least 1 cm to =< 2 cm must use spiral computed tomography (CT) imaging for both pre- and post-treatment tumor assessments; disease that has received prior radiation (performed for palliative reasons) cannot be used for measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Hemoglobin (Hgb) >= 9.0 g/dL
• Absolute neutrophil count (ANC) >= 1,500/uL
• Platelet count >= 100,000/uL
• Total bilirubin =< upper limits of normal (ULN); if liver metastases are present, total bilirubin =< 2 x ULN
• Aspartate aminotransferase (AST) =< 2.5 x ULN; if liver metastases are present, AST =< 5 x ULN
• Creatinine =< 1.25 x ULN; if > 1.25 x ULN calculated creatinine clearance must be >= 60 ml/min
• Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
• Provide informed written consent
• Willingness to return to NCCTG enrolling institution for follow-up
• Willingness to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study

You may not qualify if…

• Any of the following:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception; note: adequate contraception must be used throughout the trial and for 8 weeks after the last dose of RAD001, by both sexes
• Co-morbid systemic illnesses or other severe concurrent disease which, 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
• History of any of the following:
• Known to be human immunodeficiency virus (HIV) positive
• Known prior/current history of hepatitis related to hepatitis B or hepatitis C
• Uncontrolled intercurrent illness including, but not limited to the following:
• 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 x ULN (note: optimal glycemic control should be achieved before starting trial therapy)
• Liver disease such as cirrhosis or severe hepatic impairment
• Psychiatric illness/social situations that would limit compliance with study requirements
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 4 weeks prior to registration
• Other active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
• Untreated brain metastases; NOTE: patients with treated, stable brain metastases for at least 12 weeks prior to study entry are eligible for enrollment
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
• Active, bleeding diathesis
• Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent; topical or inhaled corticosteroids are allowed
• Currently on enzyme inducing anti-convulsants (EIACs) or other strong inducers or strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
• Current use of warfarin (Coumadin); EXCEPTION: current use of low-molecular weight heparin is allowed

Where it is running

• Front Range Cancer Specialists — Fort Collins, Colorado, United States
• Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
• Trinity Cancer Center at Trinity Medical Center - 7th Street Campus — Moline, Illinois, United States
• Study site — Moline, Illinois, United States
• Elkhart Clinic, LLC — Elkhart, Indiana, United States
• Michiana Hematology-Oncology, PC - Elkhart — Elkhart, Indiana, United States
• Elkhart General Hospital — Elkhart, Indiana, United States
• St. Francis Hospital Cancer Care Services — Indianapolis, Indiana, United States
• Howard Community Hospital — Kokomo, Indiana, United States
• Center for Cancer Therapy at LaPorte Hospital and Health Services — La Porte, Indiana, United States
• Michiana Hematology-Oncology, PC - South Bend — Mishawaka, Indiana, United States
• Saint Joseph Regional Medical Center — Mishawaka, Indiana, United States
• Michiana Hematology Oncology PC - Plymouth — Plymouth, Indiana, United States
• Reid Hospital & Health Care Services — Richmond, Indiana, United States
• CCOP - Northern Indiana CR Consortium — South Bend, Indiana, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• Michiana Hematology Oncology PC - La Porte — Westville, Indiana, United States
• McFarland Clinic, PC — Ames, Iowa, United States
• Study site — Bettendorf, Iowa, United States
• Cedar Rapids Oncology Associates — Cedar Rapids, Iowa, United States
• Mercy Regional Cancer Center at Mercy Medical Center — Cedar Rapids, Iowa, United States
• Medical Oncology and Hematology Associates - West Des Moines — Clive, Iowa, United States
• CCOP - Iowa Oncology Research Association — Des Moines, Iowa, United States
• John Stoddard Cancer Center at Iowa Methodist Medical Center — Des Moines, Iowa, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States

Full record on ClinicalTrials.gov

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