Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of successes

Safety Issue:

No

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000270681

NCT ID:

NCT00054457

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • adenocarcinoma of the stomach
  • adenocarcinoma of the esophagus
  • stage IV gastric cancer
  • recurrent gastric cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156