UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00047242
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 9, 2010
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center

October 3, 2002
January 27, 2003
August 9, 2010
August 2002
February 2006   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00047242 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors
The Pharmacokinetic and Safety Profile of UCN-01 in Combination With Irinotecan in Solid Tumors (Primarily Lung, Ovarian and GI Cancers)

RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with irinotecan in treating patients who have advanced solid tumors.


  • Determine the maximum tolerated dose and recommended phase II dose of UCN-01 and irinotecan in patients with advanced solid tumors, primarily lung, ovarian, and gastrointestinal tumors.
  • Determine the acute and chronic toxicity profile of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Determine, preliminarily, the anti-tumor effect of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive UCN-01 IV over 3 hours on day 1 and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of UCN-01 and irinotecan 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. At least 6 patients are treated at the recommended phase II dose.

Patients are followed at 1 month.

PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study within 7-15 months.

Phase 1
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: 7-hydroxystaurosporine
  • Drug: irinotecan hydrochloride
Not Provided
Jimeno A, Rudek MA, Purcell T, Laheru DA, Messersmith WA, Dancey J, Carducci MA, Baker SD, Hidalgo M, Donehower RC. Phase I and pharmacokinetic study of UCN-01 in combination with irinotecan in patients with solid tumors. Cancer Chemother Pharmacol. 2008 Mar;61(3):423-33. Epub 2007 Apr 12.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
Not Provided
February 2006   (Final data collection date for primary outcome measure)


  • Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative therapy does not exist or is no longer effective

    • Gastrointestinal, lung, and ovarian malignancies are given priority
  • No brain metastases



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal (ULN)


  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min


  • No symptomatic coronary artery disease
  • No symptomatic cardiac dysfunction
  • No symptoms suggestive of coronary artery disease
  • LVEF at least 50%


  • No symptomatic pulmonary dysfunction
  • FEV_1 greater than 75% of predicted
  • DLCO greater than 75% of predicted


  • Amylase no greater than 2 times ULN
  • No other concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No diabetes mellitus or random glucose more than 200 mg/dL
  • No prior allergic reaction attributed to compounds of similar biological or chemical composition to UCN-01 or irinotecan (including rash and systemic allergic reaction causing hypotension and respiratory distress)
  • No chronic diarrhea (more than 5 stools/day)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 14 days before, during, and for at least 30 days after study participation


Biologic therapy

  • Not specified


  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • Prior UCN-01 and irinotecan allowed

Endocrine therapy

  • Not specified


  • At least 4 weeks since prior radiotherapy and recovered
  • No prior mediastinal radiation


  • Not specified


  • At least 14 days since prior warfarin
  • No concurrent warfarin unless required for maintaining patency of existing, permanent IV catheters
  • No concurrent commercial or other investigational anticancer agents or therapies
  • No concurrent combination antiretroviral therapy for HIV-positive patients
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
JHOC-J0173, CDR0000257566
U01CA070095 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Not Provided
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Ross C. Donehower, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP