UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors

January 13, 2010 updated by: City of Hope Medical Center

Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of cisplatin when administered with UCN-01 in patients with advanced solid tumors.
  • Assess the toxicity and potential antitumor activity of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study of cisplatin.

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

Cohorts of 1-6 patients receive escalating doses of cisplatin 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.

Patients are followed every 2-3 months for at least 1 year.

PROJECTED ACCRUAL: A total of 9-30 patients will be accrued for this study within 1 year.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Pasadena, California, United States, 91105
        • City of Hope Medical Group
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David R. Gandara, MD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

November 6, 2000

First Submitted That Met QC Criteria

May 29, 2003

First Posted (Estimate)

May 30, 2003

Study Record Updates

Last Update Posted (Estimate)

January 15, 2010

Last Update Submitted That Met QC Criteria

January 13, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068274
  • P30CA033572 (U.S. NIH Grant/Contract)
  • U01CA062505 (U.S. NIH Grant/Contract)
  • CHNMC-PHI-28
  • NCI-T99-0065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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