Clinical trial: S0413 Lapatinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer (NCT00103324)

Eligibility criteria:
Inclusion Criteria:

          -  Patients must have cytologically or pathologically verified diagnosis of gastric
             cancer; patients must have locally advanced or distant metastatic disease (either
             recurrent or at primary diagnosis) that is not surgically curable

               -  The pathologic confirmation of gastric cancer may be made from the metastatic
                  site; biopsy of the primary tumor is not necessary; patients with pathologic
                  confirmation of cancer from a metastatic site, along with clinical documentation
                  of gastric involvement and no evidence of another primary are also eligible

               -  Eligible pathologic type: patients may have any histological subtype including
                  adenocarcinoma NOS, papillary carcinoma, adenocarcinoma, intestinal type, clear
                  cell adenocarcinoma, mucinous carcinoma, signet ring cell carcinoma,
                  undifferentiated carcinoma, carcinoma NOS; patients must not have carcinoid
                  tumors or sarcomas

          -  Patients must have measurable disease; x-rays, scans, or physical examinations for
             measurable disease must have been completed within 28 days prior to registration;
             x-rays, scans or physical examinations for non-measurable disease must have been
             completed within 42 days prior to registration,; all disease must be assessed

          -  Patients must be willing to have specimens submitted; the paraffin embedded specimens
             must be available for submission

          -  Patients may have had prior surgery for their gastric cancer; patients must be at
             least 2 weeks beyond surgery, and recovered from all effects of surgery

          -  Patients may have received prior chemotherapy, hormonal therapy, immunotherapy,
             radiation or chemoradiotherapy as neoadjuvant or adjuvant treatment but this must have
             been completed at least 6 months prior to documented recurrence or metastatic disease;
             patients must not have received previous treatment for metastatic disease

               -  If patient received radiation therapy, the site of measurable disease must be
                  outside of the radiation field

          -  Patients must not have had prior therapy with EGFR targeting therapies

          -  Patients must have a Zubrod performance status of 0-1

          -  Leukocytes >= 3,000/mcl

          -  Platelets >= 100,000/mcl

          -  AGC >= 1,500/mcl

          -  Serum transaminase (SGOT or SGPT) =< 2.5 x IULN; patients with liver metastases must
             have SGOT/SGPT =< 5 x IULN

          -  Bilirubin =< IULN

          -  Serum creatinine =< IULN OR measured creatinine clearance > 60 mL/min OR estimated
             creatinine clearance> 60 mL/min

          -  Patients must have cardiac ejection fraction within the institutional range of normal
             as measured by echocardiogram or MUGA scan; note that baseline and on treatment scans
             should be performed using the same modality and preferably at the same institution

          -  Patients must either be able to swallow and/or receive enteral medications via
             gastrostomy feeding tube; patients with intractable nausea or vomiting are not
             eligible; patients with GI tract disease resulting in an inability to take oral
             medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical
             procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g.,
             Crohn's, ulcerative colitis) are not eligible

          -  Patients must not have a history of allergic reactions attributed to compounds of
             similar chemical or biologic composition to GW572016

          -  There must be no plans for the patient to receive concurrent chemotherapy, hormonal
             therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of
             their cancer while on this protocol

          -  HIV-positive patients receiving combination anti-retroviral therapy are excluded from
             the study because of possible pharmacokinetic interactions with GW572016

          -  Pregnant or nursing women are not eligible because of the risk of fetal harm; nursing
             women may participate only if nursing is discontinued, due to the possibility of harm
             to nursing infants from this treatment regimen; women/men of reproductive potential
             must have agreed to use an effective contraceptive method

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             stage I or II cancer from which the patient is currently in remission or any other
             cancer from which the patient has been disease-free for 5 years

          -  If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next
             working day

               -  In calculating days of tests and measurements, the day a test or measurement is
                  done is considered day 0; therefore, if a test is done on a Monday, the Monday
                  four weeks later would be considered day 28; this allows for efficient patient
                  scheduling without exceeding the guidelines

          -  All patients must be informed of the investigational nature of this study and must
             sign and give written informed consent in accordance with institutional and federal
             guidelines

          -  At the time of patient registration, the treating institution's name and ID number
             must be provided to the Statistical Center in order to ensure that the current (within
             365 days) date of institutional review board approval for this study has been entered
             into the data base
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? Contradiction