Docetaxel and Capecitabine in Treating Patients With Metastatic Cancer of the Stomach or Gastroesophageal Junction

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054457
First received: February 5, 2003
Last updated: August 17, 2010
Last verified: August 2007
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study of the effectiveness of combining docetaxel with capecitabine in treating patients who have metastatic cancer of the stomach or gastroesophageal junction.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: capecitabine
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Docetaxel And Capecitabine In Patients With Measurable Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of successes [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival time [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Quality of life as measured by the LASA, FACT-E and Patient Uniscale Swallowing questionnaires [ Designated as safety issue: No ]
  • Genetic polymorphisms [ Designated as safety issue: No ]

Study Start Date: September 2003
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the objective tumor response rate in patients with metastatic gastric or gastroesophageal junction adenocarcinoma treated with docetaxel and capecitabine.
  • Determine the time to progression in patients treated with this regimen.
  • Determine the overall survival in patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Determine whether interleukin-1 polymorphisms are present among patients who have weight loss vs no weight loss, and their relationship to a poor prognosis.
  • Assess the quality of life and swallowing uniscale during chemotherapy in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at each tumor measurement, and at the end of treatment.

Patients are followed every 3 months until disease progression and then every 6 months until 3 years from registration.

PROJECTED ACCRUAL: A total of 15-43 patients will be accrued for this study within 24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
  • Deemed unresectable and not a candidate for potentially curative treatment (e.g., surgical resection or combined modality therapy)

    • At least 4 weeks since prior abdominal exploration with resection (3 weeks without resection)
    • No other more conventional forms of therapy available with a reasonable chance of cure or significant palliation
  • Measurable disease*

    • The following are not considered measurable disease:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging
      • Cystic lesions NOTE: *Patients having only lesions measuring ≥ 1 cm to < 2 cm must use spiral CT scan for all tumor assessments.
  • No untreated or treated but symptomatic CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN if alkaline phosphatase is less than ULN OR
  • Alkaline phosphatase no greater than 4 times ULN if AST less than ULN

Renal

  • Creatinine normal
  • Creatinine clearance at least 60 mL/min

Cardiovascular

  • No New York Heart Association class III or IV heart disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Ability to swallow capecitabine
  • No prior anaphylactic reaction to any taxane
  • No prior severe reaction to fluoropyrimidine
  • No prior poor tolerance to capecitabine
  • No known sensitivity or poor tolerance to fluorouracil
  • No known dihydropyrimidine dehydrogenase deficiency
  • No uncontrolled infection
  • No uncontrolled seizure disorder
  • No chronic debilitating disease
  • No peripheral neuropathy of any etiology greater than grade 1
  • No diabetes mellitus
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma or adequately treated noninvasive carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior immunotherapy or biologic therapy for recurrent or metastatic disease
  • No concurrent biologic therapy

Chemotherapy

  • No prior chemotherapy for recurrent or metastatic disease except for the following:

    • Adjuvant chemotherapy after complete resection of the original tumor
    • Neoadjuvant chemotherapy followed by surgical resection of the original tumor
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy except for the following:

    • Adjuvant radiotherapy after complete resection of the original tumor
    • Neoadjuvant radiotherapy followed by surgical resection of the original tumor
  • No prior radiotherapy to 25% or more of the bone marrow
  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • No prior organ allograft

Other

  • No concurrent brivudine or sorivudine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054457

Locations
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Cancer Center
St. Louis Park, Minnesota, United States, 55416
United Hospital
St. Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Aminah Jatoi, MD Mayo Clinic
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00054457     History of Changes
Other Study ID Numbers: CDR0000270681, NCCTG-N0242
Study First Received: February 5, 2003
Last Updated: August 17, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the stomach
adenocarcinoma of the esophagus
stage IV gastric cancer
recurrent gastric cancer
stage IV esophageal cancer
recurrent esophageal cancer

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014