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

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