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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054457
• Other study ID #: NCCTG-N0242
• Secondary ID: NCI-2012-02517CD
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2003
• Last updated: December 9, 2016
• Start date: September 2003
• Est. completion date: February 2008

Study information

• Verified date: December 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 of the stomach or gastroesophageal junction.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 2008
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• capecitabine

• docetaxel

Locations

Country	Name	City	State
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Southwest Medical Center	Liberal	Kansas
United States	Minnesota Oncology Hematology, PA - Maplewood	Maplewood	Minnesota
United States	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Robbinsdale	Minnesota
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	Park Nicollet Cancer Center	St. Louis Park	Minnesota
United States	United Hospital	St. Paul	Minnesota
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas
United States	Minnesota Oncology Hematology, PA - Woodbury	Woodbury	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 gastroeso — View Citation

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. — View Citation

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 gastroesophag — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of successes		Up to 3.5 years	No
Secondary	Survival time		Up to 3.5 years	No
Secondary	Time to disease progression		Up to 3.5 years	No
Secondary	Duration of response		Up to 3.5 years	No
Secondary	Time to treatment failure		Up to 3.5 years	No
Secondary	Quality of life as measured by the LASA, FACT-E and Patient Uniscale Swallowing questionnaires		Up to 3.5 years	No