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

Stopped early · Phase 2

Conditions studied: Cancer

In brief

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

Key facts

Study ID

NCT00177255

Run by

University of Pittsburgh

People needed

40

Starts

2005-04-01

Expected to finish

2008-12-01

Last updated by the study team

2016-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.