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

NCT00177255 | Terminated Phase 2 Results DMC

• 1 other identifier: 04-026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

gastric; stomach; esophagus; esophageal

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  The time interval between the date on which a patient first received protocol treatment and the documented date of death.

  2 years

Secondary Outcomes (1)

• Overall Response Rate

  Every 2 cycles (6 weeks)

Study Arms (1)

Docetaxel + Capecitabine

EXPERIMENTAL

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.

Drug: Docetaxel; Drug: Capecitabine

Interventions

Docetaxel DRUG

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.

Docetaxel + Capecitabine

Capecitabine DRUG

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.

Also known as: 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.

Docetaxel + Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Aventis Pharmaceuticals: collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Docetaxel; Capecitabine

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Nathan Bahary, MD
• Organization: University of Pittsburgh

baharyn@upmc.edu

412-864-7764

Study Officials

• Nathan Bahary, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medicine, Division of Oncology

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 8, 2016
• Results First Posted: February 8, 2016

Record last verified: 2016-01

Locations

US (1)