Status:
TERMINATED
A Study of Docetaxel in Combination With Capecitabine in Stomach and Esophagus Cancers
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Aventis Pharmaceuticals
Roche Pharma AG
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
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 administ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00177255
Start Date
April 1 2005
End Date
December 1 2008
Last Update
February 8 2016
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232