Esophageal Cancer Clinical Trial

DX-8951f in Treating Patients With Metastatic Stomach Cancer

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.

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Full Description

OBJECTIVES:

Determine the objective response rate of patients with previously untreated metastatic gastric cancer treated with exatecan mesylate (DX-8951f).
Determine the time to tumor progression in this patient population when treated with this drug.
Determine the survival at 6 and 12 months in this patient population when treated with this drug.
Determine the quantitative and qualitative toxic effects of this drug in this patient population.
Determine the pharmacokinetics of this drug in the plasma of these patients.

OUTLINE: This is a multicenter study.

Patients receive exatecan mesylate (DX-8951f) IV over 30 minutes on days 1-5. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Study ID:

NCT00017212

Recruitment Status:

Completed

Sponsor:

Daiichi Sankyo, Inc.

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There are 6 Locations for this study

See Locations Near You

Pacific Shores Medical Group
Long Beach California, 90813, United States
Rocky Mountain Cancer Centers
Denver Colorado, 80218, United States
Simmons Cancer Center - Dallas
Dallas Texas, 75235, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Cancer Therapy and Research Center
San Antonio Texas, 78229, United States
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton Ontario, L8V 5, Canada

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Study ID:

NCT00017212

Recruitment Status:

Completed

Sponsor:


Daiichi Sankyo, Inc.

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