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A Phase 1 Study of UCN-01 in Combination With Carboplatin in Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase 1 Study of UCN-01 in Combination With Carboplatin in Advanced Solid Tumors


PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose, dose limiting toxicity and other toxicities of
UCN-01 when combined with carboplatin.

II. Preliminarily evaluate the antitumor effect of the combination of carboplatin and
UCN-01.

III. Determine the pharmacokinetics of UCN-01 and carboplatin.

OUTLINE: This is a dose-escalation study.

Patients receive carboplatin IV over 1 hour followed by UCN-01 IV over 3 hours on day 1.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin and UCN-01 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.


Inclusion Criteria:



- Patients must have histologically confirmed malignancy that is metastatic or
unresectable and for which standard curative or palliative measures do not exist or
are no longer effective

- At least 4 weeks since prior chemotherapy or radiation therapy, 6 weeks if the last
regimen included BCNU or mitomycin C; include site/total dose for prior radiation
exposure as needed (e.g., no more than 3000 cGy to fields including substantial
marrow)

- ECOG performance status =< 2 (Karnofsky >= 60%)

- Life expectancy of greater than 12 weeks

- Leukocytes >= 3,000/microl

- Absolute neutrophil count >= 1,500/microl

- Platelets >= 100,000/microl

- Total bilirubin within normal institutional limits

- AST(SGOT)/ALT(SGPT) >= 2.5 X institutional upper limit of normal

- Creatinine within normal institutional limits OR creatinine clearance >= 60
mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

- Women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control) prior to study entry and for the
duration of study participation; should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- Patients may not be receiving any other investigational agents

- Patients with known brain metastases are eligible providing the brain metastases are,
in the opinion of the site investigator, asymptomatic or clinically stable after
treatment with surgery and/or radiation therapy; patients should not require steroids
or antiseizure medications and should have fully recovered from all therapy; at least
two weeks should elapse between completion of any treatment for brain metastases
(surgery, CNS irradiation) and commencement of protocol therapy

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to UCN-01 or other agents used in study

- Because of cardiopulmonary toxicity seen in patients on other studies, patients with
a symptomatic cardiac disease should be excluded; patients with a history of coronary
artery disease or mediastinal radiation should undergo testing of ventricular
function (cardiac echocardiogram, MUGA or equivalent) and are eligible if LVEF is >=
45%; if there is a history of prior pulmonary disease then pulmonary function tests
should be performed and patients are eligible if FEV1 >= 1 liter

- Because UCN-01 may cause hyperglycemia, patients with insulin dependent diabetes
mellitus should be excluded

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this; breastfeeding should be discontinued if the
mother is treated with UCN-01

- HIV-positive patients receiving combination anti-retroviral therapy are excluded from
the study

- Other drugs: Though not an exclusion criteria, every effort should be made to avoid
drugs which may bind alpha-acid glycoprotein (AGP)

- Patients with a history of severe allergic reactions to cisplatin or carboplatin

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of UCN-01 when combined with carboplatin determined by dose-limiting toxicities graded according to NCI Common Toxicity Criteria (CTC)

Outcome Time Frame:

21 days

Safety Issue:

Yes

Principal Investigator

Martin Edelman

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2013-00042

NCT ID:

NCT00036777

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms

Name

Location

University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201