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

9. juli 2013 opdateret af: Daiichi Pharmaceuticals

Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131-5636
        • University of New Mexico Cancer Research and Treatment Center
    • New York
      • New York, New York, Forenede Stater, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: Robert L. DeJager, MD, FACP, Daiichi Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Datoer for studieregistrering

Først indsendt

4. november 2003

Først indsendt, der opfyldte QC-kriterier

5. november 2003

Først opslået (Skøn)

6. november 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. juli 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2013

Sidst verificeret

1. december 2006

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • DAIICHI-1027A-PRT008
  • CDR0000339345 (Registry Identifier: PDQ (Physician Data Query))
  • CPMC-IRB-20031085
  • NCT00072228

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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