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

NCT00012194 | Terminated Phase 1

• 4 other identifiers: NCI-2012-03129DMS 9934DMS-9934NCI-2331
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

• MTD of cisplatin defined as the highest dose level in which six patients have been evaluated for toxicity with no more than one patient experiencing DLT attributable to the study drugs

  Graded using the NCI CTCAE.

  4 weeks

• Toxicity observed at each dose level, graded using the NCI CTCAE

  Summarized in terms of type, severity, time of onset, duration, and reversibility or outcome.

  Up to 7 years

Secondary Outcomes (4)

• Objective tumor response

  Up to 7 years

• Overall survival

  From registration to time of death due to any cause, assessed up to 7 years

• Time to treatment failure

  From registration to the first observation of disease progression, death due to any cause, or early discontinuation of treatment, assessed up to 7 years

• Duration of response

  Up to 7 years

Study Arms (1)

Treatment (7-hydroxystaurosporine, cisplatin)

EXPERIMENTAL

Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72 hours on day 2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: 7-hydroxystaurosporine; Drug: cisplatin; Other: laboratory biomarker analysis

Interventions

7-hydroxystaurosporine DRUG

Given IV

Also known as: UCN-01

Treatment (7-hydroxystaurosporine, cisplatin)

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Treatment (7-hydroxystaurosporine, cisplatin)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (7-hydroxystaurosporine, cisplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Interventions

7-hydroxystaurosporine; Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Raymond Perez

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2001
• First Posted: January 27, 2003
• Study Start: March 1, 2001
• Primary Completion: January 1, 2007
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

US (1)