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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer; Esophageal Cancer

Treatments: Drug: docetaxel; Drug: capecitabine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00054457

NCI-2012-02517 (Registry Identifier)

NCCTG-N0242

CDR0000270681 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

docetaxel + capecitabine

Experimental group

Description:

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.

Treatment:

Drug: capecitabine

Drug: docetaxel