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Esophageal CancerPhase 2NCT00054457

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

A Phase 2 study testing capecitabine and docetaxel in people with Esophageal Cancer and Gastric Cancer, run by Alliance for Clinical Trials in Oncology at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer, Gastric Cancer
What is being tested?
capecitabine and docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
28 sitesUnited States
Study dates
Sep 2003to Feb 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: A Phase II Study Of Docetaxel And Capecitabine In Patients With Measurable Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction

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.

Being tested
capecitabine, docetaxel
Keywords
adenocarcinoma of the stomach, adenocarcinoma of the esophagus, stage IV gastric cancer, recurrent gastric cancer, stage IV esophageal cancer, recurrent esophageal cancer
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00054457
Study groupRoleWhat they receive
docetaxel + capecitabineExperimentalPatients 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.
Receives: Drug: capecitabine; Drug: docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of successes

    Measured: Up to 3.5 years

Secondary outcomes (5)

  1. Survival time

    Measured: Up to 3.5 years

  2. Time to disease progression

    Measured: Up to 3.5 years

  3. Duration of response

    Measured: Up to 3.5 years

  4. Time to treatment failure

    Measured: Up to 3.5 years

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

    Measured: Up to 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2003 (estimated)
  2. Study startSep 2003
  3. Primary completionFeb 2007
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054457
Sponsor's protocol ID
NCCTG-N0242
Other IDs
NCI-2012-02517, CDR0000270681
Status last verified
Dec 2016
First submitted
5 Feb 2003
Last updated
13 Dec 2016
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine and docetaxel in people with Esophageal Cancer and Gastric Cancer, run by Alliance for Clinical Trials in Oncology at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of successes (time frame: Up to 3.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00054457, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.

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