NCT00006464

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of UCN-01 and cisplatin in treating patients who have advanced or metastatic solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2000

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2001

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

May 30, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

Enrollment Period

3.8 years

First QC Date

November 6, 2000

Last Update Submit

January 13, 2010

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

7-hydroxystaurosporineDRUG
cisplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced or metastatic solid tumor incurable by surgery or other standard therapy * Tumor site accessible by biopsy * No brain metastasis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 3 months Hematopoietic: * WBC at least 4,500/mm3 * Absolute neutrophil count at least 2,000/mm3 * Platelet count at least 150,000/mm3 Hepatic: * Bilirubin normal * SGOT no greater than 2.5 times upper limit of normal Renal: * Creatinine normal * Creatinine clearance at least 60 mL/min Cardiovascular: * No New York Heart Association class III or IV congestive heart failure Other: * No peripheral neuropathy greater than grade I * No history of allergic reactions to diuretics or antiemetics (e.g., 5-HT3 antagonists) that would preclude study * No other uncontrolled illness that would preclude study, including intolerance to vigorous hydration * No medical, social, or psychological factors that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered * No greater than 2 prior chemotherapy regimens * Prior cisplatin allowed if cumulative dose no greater than 400 mg/m2 Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery: * See Disease Characteristics * Recovered from any prior surgery Other: * At least 30 days since prior investigational drugs * No other concurrent investigational drugs * No other concurrent anticancer agents

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

Sponsors & Collaborators

Study Sites (4)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

City of Hope Medical Group

Pasadena, California, 91105, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Related Publications (1)

  • Lara PN Jr, Mack PC, Synold T, Frankel P, Longmate J, Gumerlock PH, Doroshow JH, Gandara DR. The cyclin-dependent kinase inhibitor UCN-01 plus cisplatin in advanced solid tumors: a California cancer consortium phase I pharmacokinetic and molecular correlative trial. Clin Cancer Res. 2005 Jun 15;11(12):4444-50. doi: 10.1158/1078-0432.CCR-04-2602.

    PMID: 15958629RESULT

MeSH Terms

Interventions

7-hydroxystaurosporineCisplatin

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • David R. Gandara, MD

    University of California, Davis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2000

First Posted

May 30, 2003

Study Start

March 1, 2001

Primary Completion

January 1, 2005

Study Completion

June 1, 2008

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

US(4)