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Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Sponsor
Daiichi Pharmaceuticals (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00072228
Collaborator
(none)
2
Locations

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as soblidotin and gemcitabine, 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: This phase I trial is studying the side effects and best dose of soblidotin and gemcitabine in treating patients with locally advanced or metastatic solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of soblidotin and gemcitabine in patients with locally advanced or metastatic solid tumors.

  • Determine the dose-limiting toxic effects of this regimen in these patients.

Secondary

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

  • Determine the pharmacokinetics of this regimen in these patients.

  • Determine, preliminarily, the antitumor activity of this regimen in these patients.

OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study.

Patients receive gemcitabine IV over 30 minutes and soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of soblidotin and gemcitabine 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 for survival every 3 months after completion of study therapy.

PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 1 year.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors

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 or cytologically confirmed locally advanced or metastatic solid tumors

    • Minimally pretreated

    • Not refractory to prior gemcitabine therapy

    • No disease progression during initial treatment with gemcitabine

    • No symptomatic brain metastases

    PATIENT CHARACTERISTICS:

    Age

    • 18 and over

    Performance status

    • ECOG 0-2

    Life expectancy

    • At least 12 weeks

    Hematopoietic

    • Absolute neutrophil count at least 1,500/mm^3

    • Platelet count at least 100,000/mm^3

    Hepatic

    • Bilirubin no greater than 1.5 times upper limit of normal (ULN)

    • SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases are present)

    Renal

    • Creatinine no greater than 1.5 times ULN

    Cardiovascular

    • Ejection fraction at least 40% by MUGA

    Other

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • No psychiatric disorder that would preclude study consent or compliance

    • No concurrent severe or uncontrolled underlying medical disease unrelated to the tumor that would compromise patient safety or affect study outcome

    • No hypersensitivity to gemcitabine

    • No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off all therapy for that disease for at least 2 years

    • No serious infection

    • No grade 2 or greater neuropathy

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • No concurrent anticancer biologic therapy

    Chemotherapy

    • See Disease Characteristics

    • Recovered from prior chemotherapy

    • No other concurrent anticancer chemotherapy

    Endocrine therapy

    • Not specified

    Radiotherapy

    • Recovered from prior radiotherapy

    • No concurrent anticancer radiotherapy

    • Concurrent localized palliative radiotherapy to a non-indicator lesion for pain control allowed only if other methods of pain control are ineffective

    Surgery

    • At least 4 weeks since prior major surgery and recovered

    Other

    • More than 28 days since prior investigational drugs, including analgesics or antiemetics

    • At least 4 weeks since prior myelosuppressive therapy

    • No other concurrent anticancer therapy

    • No other concurrent anticancer cytotoxic therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of New Mexico Cancer Research and Treatment Center Albuquerque New Mexico United States 87131-5636
    2 Herbert Irving Comprehensive Cancer Center at Columbia University New York New York United States 10032

    Sponsors and Collaborators

    • Daiichi Pharmaceuticals

    Investigators

    • Study Chair: Robert L. DeJager, MD, FACP, Daiichi Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00072228
    Other Study ID Numbers:
    • DAIICHI-1027A-PRT008
    • CDR0000339345
    • CPMC-IRB-20031085
    First Posted:
    Nov 6, 2003
    Last Update Posted:
    Jul 10, 2013
    Last Verified:
    Dec 1, 2006
    Additional relevant MeSH terms:
    Neoplasms
    Gemcitabine
    Soblidotin

    Study Results

    No Results Posted as of Jul 10, 2013