A Study of Docetaxel in Combination With Capecitabine in Stomach and Esophagus Cancers
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Purpose
This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: Docetaxel Drug: Capecitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Weekly Docetaxel (Taxotere®) in Combination With Capecitabine (Xeloda) in Advanced Gastric and Gastro-Esophageal Adenocarcinomas. |
- median survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To determine response rate [ Time Frame: survival at 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 43 |
| Study Start Date: | April 2005 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
-
Drug: Docetaxel
- 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 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.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Principal Investigator: | Kenneth Foon, MD | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | University of Pittsburgh Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00177255 History of Changes |
| Other Study ID Numbers: | 04-026 |
| Study First Received: | September 12, 2005 |
| Last Updated: | April 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Pittsburgh:
|
gastric stomach esophagus esophageal |
Additional relevant MeSH terms:
|
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Docetaxel Capecitabine |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013