Clinical trial: Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach (NCT00020761)

Eligibility criteria:
Inclusion Criteria

          -  Patients with histologic proof of adenocarcinoma of the esophagus (including GE
             junction) or adenocarcinoma of the stomach will be eligible.

          -  Location of the tumor for assignment to study will be determined by prior endoscopy or
             barium contrast study.

          -  Patients must have either metastatic or recurrent cancer.

          -  Patients must have bidimensionally measurable disease, as defined in Section 8.4.1.1,
             page 16. Mediastinal or hilar lymph nodes assessed by CT or MRI scans must be at least
             2 cm in the largest dimension to be considered measurable.

          -  Prior limited radiation therapy is permitted. Prior radiotherapy must not have
             included major bone marrow containing areas (pelvis, lumbar spine), or contained the
             single evaluable lesion in a radiation field. A recovery period of at least 4 weeks
             after completion of radiotherapy is required prior to study treatment.

          -  Patients must have an anticipated life expectancy of at least 12 weeks.

          -  Patients must have a performance status of 0 or 1 on the ECOG performance scale.

          -  Patients must be > 18 years old.

          -  Patients must give written informed consent prior to enrollment.

          -  Patients should have adequate organ function defined as follows: Absolute granulocytes
             > 1,500/mm3 and platelets > 100,000/mm3; serum bilirubin < 1.5 mg/dL and SGOT < 3X
             upper limit of institutional norm; and serum creatinine < 1.5 mg/dL.

          -  Patients must have recovered from recent surgery. One week must have elapsed from the
             time of a minor surgery and 3 weeks from major surgery.

        Exclusion Criteria

          -  Patients who have received more than one prior chemotherapy regimen or immunotherapy
             for metastatic disease. Prior 5-FU alone as an adjuvant therapy or radiosensitizer is
             not counted. Patients must have an interval of 4 weeks from prior chemotherapy or
             immunotherapy with full recovery.

          -  Patients receiving concurrent chemotherapy, immunotherapy, or radiotherapy.

          -  Patients who are potentially curable with a chemotherapy, radiotherapy, surgery, or
             any combination of the above.

          -  Patients with known brain metastases.

          -  Patients with a history of seizures or are receiving phenytoin, phenobarbital, or
             other antiepileptic prophylaxis.

          -  Pregnant or lactating women. All women of childbearing potential must have a negative
             pregnancy test prior to entry into the study. All patients of procreative potential
             must be advised of the importance of avoiding pregnancy and using appropriate methods
             of contraception while participating in this investigational trial.

          -  Patients with serious intercurrent infections, or any other concurrent disease which,
             in the investigator's judgment, would make the patient inappropriate for entry into
             this study.

          -  Patients with psychiatric disorders rendering them incapable of complying with the
             requirements of the protocol.

          -  Patients with osseous metastasis as only site of disease.

          -  Patients with any concurrent active malignancy other than non-melanoma skin cancers or
             carcinoma-in-situ of the cervix. Patients with previous malignancies but without
             evidence of disease for > 5 years will be allowed to enter the trial.

          -  Patients with known Gilbert's syndrome.

          -  Patients who have a significant clinical neuropathy of greater than grade 2.

          -  Patients with unstable angina, a history of myocardial infarction within the previous
             6 months, or current clinical evidence of congestive heart failure. Patients taking
             medication for congestive heart failure and showing no clinical signs or symptoms are
             eligible.

          -  Patients who have previously received a taxane or campthothecin

          -  Patients who have received any investigational therapy within the previous 4 weeks.
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? Entailment