RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have locally advanced or metastatic stomach cancer that cannot be removed during surgery.

Condition	Treatment or Intervention	Phase
stage III gastric cancer stage III esophageal cancer stage IV esophageal cancer Adenocarcinoma of the Esophagus recurrent gastric cancer stage IV gastric cancer recurrent esophageal cancer adenocarcinoma of the stomach	Procedure: chemotherapy  Drug: nitrocamptothecin	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the objective response rate, progression free survival, overall survival, and time to treatment failure in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with oral nitrocamptothecin. II. Determine the toxicity of this regimen in these patients.

PROTOCOL OUTLINE: Patients are stratified according to prior therapy (yes vs no). Patients receive oral nitrocamptothecin on days 1-5. Treatment repeats every week for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after week 8 may receive additional courses. Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: Approximately 21-55 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction; No prior immunotherapy or chemotherapy OR Failure after no more than 1 prior regimen of immunotherapy or chemotherapy (including chemotherapy as radiosensitizer); Primarily resistant or responsive disease but with subsequent progression
• No osseous metastasis as only site of disease
• Bidimensionally measurable or evaluable disease; Mediastinal or hilar lymph nodes must be at least 1.5 cm in diameter by CT or MRI scan to be considered measurable
• No brain metastases

--Prior/Concurrent Therapy--

• Biologic therapy: See Disease Characteristics; No concurrent immunotherapy including filgrastim (G-CSF)
• Chemotherapy: See Disease Characteristics; No prior topoisomerase I inhibitors (e.g., irinotecan, topotecan, or aminocamptothecin); At least 4 weeks since other prior chemotherapy and recovered; No other concurrent chemotherapy
• Endocrine therapy: No concurrent anticancer hormonal therapy
• Radiotherapy: No prior radiotherapy to major bone marrow containing areas (pelvis, lumbar spine); No prior radiotherapy to sole indicator lesion; At least 4 weeks since prior limited radiotherapy and recovered; No concurrent radiotherapy
• Surgery: At least 1 week since prior minor surgery and recovered; At least 3 weeks since prior major surgery and recovered
• Other: No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis

--Patient Characteristics--

• Age: 18 and over
• Performance status: Zubrod 0 or 1 Karnofsky 80-100%
• Life expectancy: At least 12 weeks
• Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 8 g/dL
• Hepatic: Bilirubin no greater than 1.5 mg/dL; No Gilbert's syndrome
• Renal: Creatinine no greater than 1.5 mg/dL; Calcium no greater than 12 mg/dL OR No symptomatic hypercalcemia under treatment
• Cardiovascular: No New York Heart Association class III or IV heart disease; No angina, myocardial infarction, or congestive heart failure within the past 6 months
• Gastrointestinal: No intestinal obstruction; No diarrhea (greater than 4 stools per day); Able to swallow
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No concurrent serious infection or nonmalignant medical illness that is uncontrolled or for which control may be jeopardized by complications of study therapy; No history of seizures; No psychiatric disorder that would preclude compliance; No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix; No preexisting cystitis

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Show-Li Sun,  Study Chair,  SuperGen   

Study ID Numbers:  CDR0000067912; SUPERGEN-RFS2000-30; MDA-DM-99231
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005876
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08