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Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer

1 mei 2015 bijgewerkt door: National Cancer Institute (NCI)

Phase Ib/II Neoadjuvant Trial of the Farnesyltransferase Inhibitor, R115777 With Docetaxel and Capecitabine for Patients With Stage IIIA or IIIB Breast Cancer

Phase I/II trial to study the effectiveness of neoadjuvant tipifarnib combined with docetaxel and capecitabine in treating patients who have locally advanced or metastatic solid tumors or stage IIIA or stage IIIB breast cancer. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy, such as docetaxel and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining tipifarnib with docetaxel and capecitabine may kill more tumor cells.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose and recommended dose of capecitabine in combination with docetaxel and tipifarnib in patients with locally advanced or metastatic solid tumors. (Phase Ib) II. Determine the complete pathological and clinical response rate in patients with stage IIIA or IIIB breast cancer treated with this regimen. (Phase II)

SECONDARY OBJECTIVES:

I. Determine the toxicity of this regimen in these patients. II. Determine disease-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of capecitabine. Patients in phase II are stratified according to type of breast cancer (inflammatory vs noninflammatory).

Phase Ib: Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14 and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of capecitabine 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.

Phase II: Patients receive oral tipifarnib twice daily for 6 days. Beginning at least 48 hours after completion of the initial dose of tipifarnib, patients receive treatment as in phase Ib for up to 6 courses at the MTD of capecitabine. Patients in phase Ib are followed at 3 months.

Patients in phase II are followed every 4 months for up to 5 years.

PROJECTED ACCRUAL: A total of 24-53 patients (9-18 for phase Ib and 15-35 for phase II) will be accrued for this study within 14-35 months.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

53

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Arizona
      • Scottsdale, Arizona, Verenigde Staten, 85259
        • Mayo Clinic in Arizona
    • District of Columbia
      • Washington, District of Columbia, Verenigde Staten, 20060
        • Howard University Cancer Center CCOP
    • Florida
      • Jacksonville, Florida, Verenigde Staten, 32224-9980
        • Mayo Clinic in Florida
    • Michigan
      • Detroit, Michigan, Verenigde Staten, 48201
        • Barbara Ann Karmanos Cancer Institute
    • Minnesota
      • Rochester, Minnesota, Verenigde Staten, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, Verenigde Staten, 63110
        • Washington University School of Medicine
    • Wisconsin
      • Milwaukee, Wisconsin, Verenigde Staten, 53201
        • University of Wisconsin Medical School

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Histologically or cytologically confirmed solid tumor

    • Locally advanced or metastatic
  • No known standard therapy that is potentially curative or definitely capable of extending life expectancy

  • No history of metastatic brain disease within the past 6 months

    • Treated metastatic brain disease is allowed provided disease has been stable for more than 6 months and does not require concurrent steroids or anti-seizure medication

  • Histologically confirmed breast cancer

    • Stage IIIA or stage IIIB, including ipsilateral palpable supraclavicular lymph node(s) without other distant metastasis

    • Invasive disease confirmed by 1 of the following*:

      • Incisional biopsy
      • Punch biopsy (applicable for clinical T4b tumors)
      • Core needle (cutting needle) biopsies
  • No distant metastatic disease

  • Hormone receptor status:

    • Not specified
  • Male or female
  • Performance status - ECOG 0-1
  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL
  • Bilirubin no greater than upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN
  • AST no greater than 2.5 times ULN
  • Creatinine no greater than 1.25 times ULN
  • Creatinine clearance at least 50 mL/min
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics
  • No diabetes
  • No symptomatic neurologic condition
  • No other uncontrolled serious medical condition
  • No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No history of hypersensitivity to intravenous paclitaxel or other medication containing Cremophor EL or polysorbate 80 as a carrier (phase Ib)

  • Phase Ib only:

    • More than 4 weeks since prior immunotherapy
    • More than 4 weeks since prior biologic therapy
    • No concurrent immunotherapy

  • Phase Ib and II:

    • No concurrent prophylactic filgrastim (G-CSF)

  • Phase Ib only:

    • More than 1 year since prior adjuvant docetaxel before metastatic relapse
    • More than 4 weeks since prior chemotherapy and recovered

    • No prior capecitabine AND docetaxel (in combination or as single agents)

      • Prior capecitabine OR docetaxel allowed
    • No other concurrent chemotherapy

  • Phase II only:

    • No prior cytotoxic chemotherapy for breast cancer

  • Phase Ib only:

    • More than 3 weeks since prior radiotherapy
    • No prior radiotherapy to more than 25% of bone marrow
    • No concurrent radiotherapy

  • Phase II only:

    • No prior radiotherapy for breast cancer

  • Phase Ib only:

    • More than 4 weeks since prior major surgery

  • Phase II only:

    • No prior surgery (other than core or incisional biopsy for diagnostic purposes) for breast cancer

  • Phase Ib only:

    • No other ancillary investigational therapy

  • Phase Ib and II:

    • No concurrent sorivudine or brivudine

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Treatment (tipifarnib, capecitabine, docetaxel)

Phase Ib: Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14 and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Phase II: Patients receive oral tipifarnib twice daily for 6 days. Beginning at least 48 hours after completion of the initial dose of tipifarnib, patients receive treatment as in phase Ib for up to 6 courses at the MTD of capecitabine.
Ander: Laboratorium Biomarker Analyse
Correlatieve studies
Ander: Farmacologische studie
Correlatieve studies
Geneesmiddel: Docetaxel
IV gegeven
Andere namen:
  • Taxoter
  • RP56976
  • Taxotere injectieconcentraat
Geneesmiddel: Capecitabine
Gegeven PO
Andere namen:
  • Xeloda
  • Ro 09-1978/000
Geneesmiddel: Tipifarnib
Given orally (PO)
Andere namen:
  • R115777
  • Zarnestra

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Dose-limiting toxicity (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Phase I)
Tijdsspanne: 21 days
21 days
Pathologic complete response rate (Phase II)
Tijdsspanne: Up to 5 years
Estimated by the number of patients with a complete pathologic response divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response probability will be calculated according to the approach of Duffy and Santner.
Up to 5 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinical tumor response (complete response [CR] or partial response [PR]) (Phase I)
Tijdsspanne: Up to 5 years
Clinical responses will be summarized by simple descriptive summary statistics.
Up to 5 years
Overall survival
Tijdsspanne: From registration to death due to any cause, assessed up to 5 years
The distribution of survival time will be estimated using the method of Kaplan-Meier.
From registration to death due to any cause, assessed up to 5 years
Toxicity as assessed by the National Cancer Institute (NCI) CTCAE version 3.0
Tijdsspanne: Up to 5 years
Up to 5 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Philip Philip, Mayo Clinic

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2003

Primaire voltooiing (Werkelijk)

1 februari 2006

Studie voltooiing (Werkelijk)

1 juni 2010

Studieregistratiedata

Eerst ingediend

3 oktober 2003

Eerst ingediend dat voldeed aan de QC-criteria

6 oktober 2003

Eerst geplaatst (Schatting)

7 oktober 2003

Updates van studierecords

Laatste update geplaatst (Schatting)

4 mei 2015

Laatste update ingediend die voldeed aan QC-criteria

1 mei 2015

Laatst geverifieerd

1 december 2012

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NCI-2012-01442 (Register-ID: CTRP (Clinical Trial Reporting Program))
  • P30CA015083 (Subsidie/contract van de Amerikaanse NIH)
  • N01CM62205 (Subsidie/contract van de Amerikaanse NIH)
  • WSU-C-2679
  • MAYO-MC0131
  • NCI-5599
  • CDR0000331694
  • MC0131 (Andere identificatie: Mayo Clinic)
  • 5599 (Andere identificatie: CTEP)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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