Tanespimycin, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

This phase I trial studies the side effects, best way to give, and best doses of tanespimycin with or without gemcitabine hydrochloride and cisplatin in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as tanespimycin, gemcitabine hydrochloride, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Using more than one drug (combination chemotherapy) may kill more tumor cells.

Key facts

Study ID

NCT00047047

Run by

National Cancer Institute (NCI)

People needed

78

Starts

2002-08-01

Last updated by the study team

2013-06-04

Who can join

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

You may qualify if…

• Histologic proof of cancer that is now considered clinically unresectable
• Absolute neutrophil count (ANC) >= 1500/uL
• Platelets (PLT) >= 100,000/uL
• Total bilirubin =< 2 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) =< 2.5 x ULN
• Creatinine =< 1.5 x ULN
• Alkaline phosphatase =< 2 x ULN or =< 5 x ULN if liver involvement
• Hemoglobin (Hgb) >= 9.0 g/dL
• Ability to provide informed consent
• Willingness to return to Mayo Clinic Rochester for follow up
• Life expectancy >= 12 weeks
• Willingness to provide all biologic specimens as required by the protocol; this is the mandatory translational research component
• Prior treatment with gemcitabine or cisplatin or both is allowed
• Patients who have had prior anthracycline must have a normal ejection fraction on multi gated acquisition scan (MUGA)
• Women of childbearing potential only: negative serum pregnancy test done =< 7 days prior to registration

You may not qualify if…

• Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
• ECOG performance status (PS) 2, 3 or 4
• Uncontrolled infection
• Any of the following prior therapies:
• Chemotherapy =< 4 weeks prior to study entry
• Mitomycin C/nitrosoureas =< 6 weeks prior to study entry
• Immunotherapy =< 4 weeks prior to study entry
• Biologic therapy =< 4 weeks prior to study entry
• Radiation therapy =< 4 weeks prior to study entry, or any radiation that potentially included the heart in the field (e.g., mantle)
• Radiation to > 25% of bone marrow
• Radiopharmaceuticals
• Chest radiation
• Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
• Significant cardiac disease including:
• Heart failure that meets New York Heart Association classification III or IV
• History of myocardial infarction =< one year of study entry
• Uncontrolled dysrhythmias or requiring antiarrhythmic drugs, or
• Poorly controlled angina
• Active ischemic heart disease =< 12 months prior to study entry
• Congenital long QT syndrome
• Left bundle branch block
• Central nervous system (CNS) metastases or seizure disorder
• Any of the following:
• Pregnant women
• Nursing women

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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