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CompletedNCT00054457Updated Dec 13, 2016

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

A Phase 2 interventional study of capecitabine and docetaxel in Esophageal Cancer and Gastric Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 28 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-13.

Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Esophageal Cancer
  • Gastric Cancer

Keywords

  • adenocarcinoma of the stomach
  • adenocarcinoma of the esophagus
  • stage IV gastric cancer
  • recurrent gastric cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 46 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    docetaxel + capecitabine

    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.

    Drug: capecitabine · Drug: docetaxel

Interventions

  • Drugcapecitabine
  • Drugdocetaxel
06

What researchers measure

Primary outcomes

  1. Proportion of successes

    Time frame: Up to 3.5 years

Secondary outcomes

  1. Survival time

    Time frame: Up to 3.5 years

  2. Time to disease progression

    Time frame: Up to 3.5 years

  3. Duration of response

    Time frame: Up to 3.5 years

  4. Time to treatment failure

    Time frame: Up to 3.5 years

  5. Quality of life as measured by the LASA, FACT-E and Patient Uniscale Swallowing questionnaires

    Time frame: Up to 3.5 years

07

Study locations

28 sites
  • Cancer Center of Kansas, PA - Chanute
    Chanute, Kansas 66720, United States
  • Cancer Center of Kansas, PA - Dodge City
    Dodge City, Kansas 67801, United States
  • Cancer Center of Kansas, PA - El Dorado
    El Dorado, Kansas 67042, United States
  • Cancer Center of Kansas, PA - Kingman
    Kingman, Kansas 67068, United States
  • Southwest Medical Center
    Liberal, Kansas 67901, United States
  • Cancer Center of Kansas, PA - Newton
    Newton, Kansas 67114, United States
  • Cancer Center of Kansas, PA - Parsons
    Parsons, Kansas 67357, United States
  • Cancer Center of Kansas, PA - Pratt
    Pratt, Kansas 67124, United States
  • Cancer Center of Kansas, PA - Salina
    Salina, Kansas 67042, United States
  • Cancer Center of Kansas, PA - Wellington
    Wellington, Kansas 67152, United States
  • Associates in Womens Health, PA - North Review
    Wichita, Kansas 67203, United States
  • Cancer Center of Kansas, PA - Medical Arts Tower
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas, PA - Wichita
    Wichita, Kansas 67214, United States
  • CCOP - Wichita
    Wichita, Kansas 67214, United States
  • Via Christi Cancer Center at Via Christi Regional Medical Center
    Wichita, Kansas 67214, United States
  • Cancer Center of Kansas, PA - Winfield
    Winfield, Kansas 67156, United States
  • Fairview Ridges Hospital
    Burnsville, Minnesota 55337, United States
  • Mercy and Unity Cancer Center at Mercy Hospital
    Coon Rapids, Minnesota 55433, United States
  • Fairview Southdale Hospital
    Edina, Minnesota 55435, United States
  • Mercy and Unity Cancer Center at Unity Hospital
    Fridley, Minnesota 55432, United States
  • Minnesota Oncology Hematology, PA - Maplewood
    Maplewood, Minnesota 55109, United States
  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
    Robbinsdale, Minnesota 55422-2900, United States
  • CCOP - Metro-Minnesota
    Saint Louis Park, Minnesota 55416, United States
  • Park Nicollet Cancer Center
    St. Louis Park, Minnesota 55416, United States
  • United Hospital
    St. Paul, Minnesota 55102, United States
  • Ridgeview Medical Center
    Waconia, Minnesota 55387, United States
  • Minnesota Oncology Hematology, PA - Woodbury
    Woodbury, Minnesota 55125, United States
08

References and documents

Publications

  • Jatoi A, Foster NR, Egner JR, Burch PA, Stella PJ, Rubin J, Dakhil SR, Sargent DJ, Murphy BR, Alberts SR. Older versus younger patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and stomach: a pooled analysis of eight consecutive North Central Cancer Treatment Group (NCCTG) trials. Int J Oncol. 2010 Mar;36(3):601-6. doi: 10.3892/ijo_00000535. PubMed 20126980 ↗
  • Jatoi A, Nguyen PL, Foster N, Sun D, Stella PJ, Campbell M, Tschetter LK, Dakhil SR, Mailliard JA, Nikcevich DA. Interleukin-1 genetic polymorphisms and their relationship to the cancer anorexia/weight loss syndrome in metastatic gastric and gastroesophageal junction adenocarcinoma. J Support Oncol. 2007 Jan;5(1):41-6. PubMed 17265786 ↗
  • Giordano KF, Jatoi A, Stella PJ, Foster N, Tschetter LK, Alberts SR, Dakhil SR, Mailliard JA, Flynn PJ, Nikcevich DA; North Central Cancer Treatment Group. Docetaxel and capecitabine in patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction: a phase II study from the North Central Cancer Treatment Group. Ann Oncol. 2006 Apr;17(4):652-6. doi: 10.1093/annonc/mdl005. Epub 2006 Feb 23. PubMed 16497828 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00054457
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Feb 6, 2003
Start date
Sep 2003
Primary completion
Feb 2007
Completion
Feb 2008
Last update
Dec 13, 2016

Study contacts

Aminah Jatoi, MD
study chair · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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