- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00177255
A Study of Docetaxel in Combination With Capecitabine in Stomach and Esophagus Cancers
A Phase II Study of Weekly Docetaxel (Taxotere®) in Combination With Capecitabine (Xeloda) in Advanced Gastric and Gastro-Esophageal Adenocarcinomas.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15232
- University of Pittsburgh Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Have histologically or cytologically confirmed locally advanced (unresectable) or metastatic adenocarcinoma of gastric, gastro-esophageal, or esophageal origin.
- Must have measurable or evaluable disease.
- Received adjuvant therapy are eligible if adjuvant therapy was given ≥ 6 months prior to the diagnosis of metastatic disease.
- Life expectancy greater than 12 weeks.
- ECOG performance status < 2.
- Adequate organ and marrow function.
- Preexisting peripheral neuropathy if present must be grade 0 or 1.
- 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:
- No chemotherapy or radiotherapy within 4 weeks
- Not receiving any other investigational agents or participate in any investigational drug study within 4 weeks preceding the start of study treatment.
- Patients with known brain metastases shall be excluded from this clinical trial
- 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.
- History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel, capecitabine or 5-FU.
- Uncontrolled intercurrent illness
- Pregnant or breast feeding women are excluded from this study
- Inability to swallow tablets or those who have malabsorptive symptoms will be excluded.
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel or capecitabine.
- Prior use of docetaxel or capecitabine is not allowed ( Prior 5FU therapy is allowed).
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
- Major surgery ( i.e laparotomy, line placement is not considered major surgery)within 4 weeks of the start of study treatment, without complete recovery.
- Known, existing uncontrolled coagulopathy.
- Patients on anticonvulsants that are metabolized via P450 3A4 pathway.
Studieplan
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:
|
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
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 04-026
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