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A Study of Docetaxel in Combination With Capecitabine in Stomach and Esophagus Cancers

10. januar 2016 oppdatert av: Nathan Bahary, MD, University of Pittsburgh

A Phase II Study of Weekly Docetaxel (Taxotere®) in Combination With Capecitabine (Xeloda) in Advanced Gastric and Gastro-Esophageal Adenocarcinomas.

This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas.

Studieoversikt

Status

Avsluttet

Forhold

Detaljert beskrivelse

This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas. Docetaxel 30mg/m2 will be administered on days 1 and 8 of each cycle and capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14) of each cycle. Each cycle is 21 days. Subjects will receive unlimited cycles of docetaxel and capecitabine until there is evidence of disease progression or unacceptable side effects.

Studietype

Intervensjonell

Registrering (Faktiske)

40

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15232
        • University of Pittsburgh Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Have histologically or cytologically confirmed locally advanced (unresectable) or metastatic adenocarcinoma of gastric, gastro-esophageal, or esophageal origin.
  2. Must have measurable or evaluable disease.
  3. Received adjuvant therapy are eligible if adjuvant therapy was given ≥ 6 months prior to the diagnosis of metastatic disease.
  4. Life expectancy greater than 12 weeks.
  5. ECOG performance status < 2.
  6. Adequate organ and marrow function.
  7. Preexisting peripheral neuropathy if present must be grade 0 or 1.
  8. Women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 3 months thereafter. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential

Exclusion Criteria:

  1. No chemotherapy or radiotherapy within 4 weeks
  2. Not receiving any other investigational agents or participate in any investigational drug study within 4 weeks preceding the start of study treatment.
  3. Patients with known brain metastases shall be excluded from this clinical trial
  4. Patients with evidence or history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant that precludes informed consent or interferes with the compliance of oral drug intake will also be excluded.
  5. History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
  6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel, capecitabine or 5-FU.
  7. Uncontrolled intercurrent illness
  8. Pregnant or breast feeding women are excluded from this study
  9. Inability to swallow tablets or those who have malabsorptive symptoms will be excluded.
  10. HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel or capecitabine.
  11. Prior use of docetaxel or capecitabine is not allowed ( Prior 5FU therapy is allowed).
  12. Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
  13. Major surgery ( i.e laparotomy, line placement is not considered major surgery)within 4 weeks of the start of study treatment, without complete recovery.
  14. Known, existing uncontrolled coagulopathy.
  15. Patients on anticonvulsants that are metabolized via P450 3A4 pathway.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Docetaxel + Capecitabine

Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.

Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).

Each cycle will consist of 21 days. Cycle 2 will begin on day 22.

Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.

Cycle 2 will begin on day 22.

Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).

Each cycle will consist of 21 days.

Cycle 2 will begin on day 22.

Andre navn:
  • Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
  • Each cycle will consist of 21 days.
  • Cycle 2 will begin on day 22.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival
Tidsramme: 2 years
The time interval between the date on which a patient first received protocol treatment and the documented date of death.
2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Response Rate
Tidsramme: Every 2 cycles (6 weeks)
The number of responders (complete responders + partial responders) divided by the number of evaluable patients.
Every 2 cycles (6 weeks)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2005

Primær fullføring (Faktiske)

1. desember 2008

Studiet fullført (Faktiske)

1. desember 2008

Datoer for studieregistrering

Først innsendt

12. september 2005

Først innsendt som oppfylte QC-kriteriene

12. september 2005

Først lagt ut (Anslag)

15. september 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. februar 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. januar 2016

Sist bekreftet

1. januar 2016

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Docetaxel

3
Abonnere