A Study of Docetaxel in Combination With Capecitabine in Stomach and Esophagus Cancers.
Information source: University of Pittsburgh
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: Docetaxel (Drug); Capecitabine (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s):
Kenneth Foon, MD, Principal Investigator, Affiliation: University of Pittsburgh
Summary
This is a phase II study that will investigate weekly dosing of docetaxel in combination with
capecitabine in advanced gastric and gastro-esophageal adenocarcinomas.
Clinical Details
Official title: A Phase II Study of Weekly Docetaxel (Taxotere®) in Combination With Capecitabine (Xeloda) in Advanced Gastric and Gastro-Esophageal Adenocarcinomas.
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To determine the median survival.
Secondary outcome: To determine response rate, time to progression, and 1 & 2 year survival.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 ³ 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.
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.
Locations and Contacts
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15232, United States
Additional Information
Starting date: April 2005
Ending date: April 2008
Last updated: March 16, 2007
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