Clinical trial: Docetaxel and Capecitabine in Treating Patients With Metastatic Cancer of the Stomach or Gastroesophageal Junction (NCT00054457)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? 1