7-hydroxystaurosporine and Cisplatin in Treating Patients With Advanced Malignant Solid Tumors

Stopped early · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

Phase I trial to study the effectiveness of combining UCN-01 with cisplatin in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help cisplatin kill more cancer cells by making tumor cells more sensitive to the drug.

Key facts

Study ID

NCT00012194

Run by

National Cancer Institute (NCI)

People needed

30

Starts

2001-03-01

Last updated by the study team

2013-07-09

Who can join

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

You may qualify if…

• Advanced or metastatic, histologcally/cytologically confirmed malignant solid tumor, not expected to clinically benefit from standard therapy
• Life expectancy greater than 3 months
• Previous chemotherapy and/or radiotherapy must have been completed at least four weeks (six weeks for prior treatment with mitomycin or nitrosoureas) and patients should have recovered from all toxicities of that therapy before treatment under this protocol
• All patients must have recovered from any surgical procedure
• Serum creatinine must be within the institutional limits of normal and an estimated creatinine clearance of >= 60 ml/min
• Normal bilirubin is required
• SGOT/AST must be less than or equal to 2.5 times the upper limit of institutional normal
• WBC >= 4000/mm\^3
• Absolute neutrophil count >= 2000/mm\^3
• Platelet count >= 150,000/mm\^3
• Patients must have a Karnofsky Performance Status of 60% or greater
• Subjects who are fertile must use a medically acceptable contraceptive throughout the treatment period and for three months following cessation of treatment; subjects must be made aware, before entering this trial, of the risk in becoming pregnant or in fathering children
• A signed informed consent (approved by the IRB) must be obtained prior to trial entry
• Tumor site accessible for both pre-treatment and post-treatment biopsy is preferred during dose-finding, and is required for patients entering the expanded cohort at the MTD
• All patients require a central indwelling venous catheter prior to treatment under this protocol

You may not qualify if…

• Peripheral neuropathy > grade I
• Any prior mediastinal radiotherapy
• Any history of coronary artery disease
• Class III or IV congestive heart failure according to the New York Heart Classification
• History of allergic reactions to appropriate diuretics or antiemetics (e.g., 5-HT3 antagonists) to be administered in conjunction with protocol directed chemotherapy
• Brain metastasis
• Uncontrolled intercurrent illness that would preclude tolerance and completion of the protocol treatment, including vigorous hydration prior and subsequent to cisplatin therapy
• Lactating or pregnant women are excluded to avoid potential harm to the unborn child or infant; documentation of a negative, serum beta-HCG pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause
• Receipt of any investigational drug within 30 days before beginning treatment with study drug
• Medical, social, or psychological factors that would prevent the patient from completing the treatment protocol
• Patients with clinically significant hearing loss

Where it is running

• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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