NCT00047242

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Last Updated

August 9, 2010

Status Verified

August 1, 2010

Enrollment Period

3.5 years

First QC Date

October 3, 2002

Last Update Submit

August 5, 2010

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

7-hydroxystaurosporineDRUG
irinotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin normal * AST/ALT no greater than 2.5 times upper limit of normal (ULN) Renal * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular * No symptomatic coronary artery disease * No symptomatic cardiac dysfunction * No symptoms suggestive of coronary artery disease * LVEF at least 50% Pulmonary * No symptomatic pulmonary dysfunction * FEV\_1 greater than 75% of predicted * DLCO greater than 75% of predicted Other * 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 PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * 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 Radiotherapy * At least 4 weeks since prior radiotherapy and recovered * No prior mediastinal radiation Surgery * Not specified Other * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

  • 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. doi: 10.1007/s00280-007-0485-9. Epub 2007 Apr 12.

    PMID: 17429623RESULT

MeSH Terms

Interventions

7-hydroxystaurosporineIrinotecan

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Ross C. Donehower, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2002

First Posted

January 27, 2003

Study Start

August 1, 2002

Primary Completion

February 1, 2006

Last Updated

August 9, 2010

Record last verified: 2010-08

Locations

US(1)