DX-8951f in Treating Patients With Metastatic Stomach Cancer

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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 exatecan mesylate in treating patients who have metastatic stomach cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Camptothecin; Exatecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed gastric or gastroesophageal adenocarcinoma

• Lymph node involvement and/or distant metastasis

• No squamous cell carcinoma, small cell carcinoma, lymphoma, or leiomyosarcoma of the stomach

• Measurable disease with indicator lesions outside the field of prior radiotherapy

• At least 20 mm by conventional scan OR

• At least 10 mm by spiral CT scan

• Nonmeasurable lesions include the following:

• Primary tumor

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural/pericardial effusion

• Inflammatory breast disease

• Lymphangitis cutis/pulmonitis

• Cystic lesions

• Abdominal masses not confirmed and followed by imaging techniques

• No prior treatment for locally advanced or metastatic disease

• Prior adjuvant treatment allowed if disease recurrence noted at least 6 months after completion of adjuvant treatment

• No known brain 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/mm3

• Platelet count at least 100,000/mm3

• Hemoglobin at least 9.0 g/dL

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

• AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)

• Albumin at least 2.8 g/dL

• PT or INR no greater than 1.5 times ULN (coumadin independent)

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No active congestive heart failure

• No uncontrolled angina

• No myocardial infarction within the past 6 months

Other:

• No concurrent serious infection

• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No overt psychosis, mental disability, or incompetence that would preclude informed consent

• No other life-threatening illness

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Biologic therapy:

• No concurrent anti-cancer biologic therapy

• No concurrent prophylactic colony stimulating factors during first course of therapy

Chemotherapy:

• Recovered from prior adjuvant chemotherapy

• No other concurrent anti-cancer chemotherapy

• No other concurrent anti-cancer cytotoxic therapy

Endocrine therapy:

• Concurrent megestrol for appetite stimulation allowed

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

• No prior wide-field radiotherapy to more than 25% of bone marrow

• No concurrent anti-cancer radiotherapy

Surgery:

• At least 4 weeks since prior major surgery and recovered

• No concurrent anti-cancer surgery

Other:

• No other investigational drugs (including analgesics or antiemetics) for at least 4 weeks prior to, during, and for 4 weeks after study