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Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

Sponsor
Case Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00006372
Collaborator
National Cancer Institute (NCI) (NIH)
10
Enrollment
1
Location
60
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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 combination chemotherapy in treating patients who have advanced solid tumors.

Condition or Disease Intervention/Treatment Phase
  • Drug: gemcitabine hydrochloride
  • Drug: pegylated liposomal doxorubicin hydrochloride
  • Drug: vinorelbine ditartrate
 Phase 1

Detailed Description

OBJECTIVES:

  • Determine the pharmacokinetic profile of gemcitabine, doxorubicin HCl liposome, and vinorelbine in patients with advanced solid tumors.

  • Determine the maximum tolerated dose of this regimen in these patients.

  • Determine the toxicity profile of this regimen in these patients.

OUTLINE: This is a dose escalation study.

Patients receive doxorubicin HCl liposome IV over 1-2.5 hours on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and vinorelbine IV over 6-10 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome, gemcitabine, and vinorelbine 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 3 months for up to 1 year.

PROJECTED ACCRUAL: Approximately 9-24 patients will be accrued for this study within 12-18 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Trial of Combination Pegylated Liposomal Doxorubicin (Doxil), Vinorelbine, and Gemcitabine
Study Start Date :
Feb 1, 2000
Actual Primary Completion Date :
Apr 1, 2003
Actual Study Completion Date :
Feb 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed solid tumor not amenable to curative surgery, radiotherapy, or chemotherapy

    • No brain metastases or primary brain tumors

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • ECOG 0-2
    Life expectancy:
    • At least 12 weeks
    Hematopoietic:

    • WBC at least 3,500/mm3

    • Absolute neutrophil count at least 1,500/mm3

    • Platelet count at least 100,000/mm3

    • Hemoglobin greater than 10 g/dL

    Hepatic:

    • Bilirubin no greater than 1.2 mg/dL

    • AST and/or ALT less than 2.5 times upper limit of normal (ULN)

    • PT no greater than ULN (anticoagulant independent)

    Renal:

    • Creatinine no greater than 1.5 mg/dL AND/OR

    • Creatinine clearance greater than 60 mL/min

    Cardiovascular:

    • No New York Heart Association class III or IV heart disease

    • LVEF at least 45% by MUGA or echocardiogram

    Other:

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:

    • No prior bone marrow or peripheral blood stem cell transplantation following high dose chemotherapy

    • At least 3 weeks since prior biologic therapy for cancer and recovered

    • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

    Chemotherapy:

    • See Disease Characteristics

    • See Biologic therapy

    • No more than 1 prior chemotherapy regimen

    • No prior vinca alkaloids

    • Prior anthracycline allowed if total dose no greater than 300 mg/m2

    • At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or carmustine) and recovered

    Endocrine therapy:
    • At least 3 weeks since prior endocrine therapy for cancer and recovered
    Radiotherapy:

    • See Disease Characteristics

    • No more than 1 prior radiotherapy regimen

    • At least 4 weeks since prior large field radiotherapy

    • At least 3 weeks since prior radiotherapy for cancer and recovered

    Surgery:
    • Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center Cleveland Ohio United States 44106-5055

    Sponsors and Collaborators

    • Case Comprehensive Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Beth A. Overmoyer, MD, FACP, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00006372
    Other Study ID Numbers:
    • CWRU1Y99
    • P30CA043703
    • CWRU-1Y99
    • NCI-G00-1859
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 11, 2010
    Last Verified:
    Jun 1, 2010
    Keywords provided by , ,
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Gemcitabine
    Doxorubicin
    Liposomal doxorubicin
    Vinorelbine

    Study Results

    No Results Posted as of Jun 11, 2010