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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Docetaxel

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