DX-8951f in Treating Patients With Metastatic Stomach Cancer

NCT ID: NCT00017212

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2003-09-30

Brief 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.

Detailed 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.

Conditions

Esophageal Cancer; Gastric Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

exatecan mesylate

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert L. DeJager, MD, FACP

Role: STUDY_CHAIR

Daiichi Sankyo

Locations

Pacific Shores Medical Group

Long Beach, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Simmons Cancer Center - Dallas

Dallas, Texas, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Cancer Therapy and Research Center

San Antonio, Texas, United States

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, Canada

Countries

United States; Canada

References

Ajani JA, Takimoto C, Becerra CR, Silva A, Baez L, Cohn A, Major P, Kamida M, Feit K, De Jager R. A phase II clinical and pharmacokinetic study of intravenous exatecan mesylate (DX-8951f) in patients with untreated metastatic gastric cancer. Invest New Drugs. 2005 Oct;23(5):479-84. doi: 10.1007/s10637-005-2907-z.

Reference Type: RESULT

PMID: 16133799 (View on PubMed)

Other Identifiers

DAIICHI-8951A-PRT028

Identifier Type: -

Identifier Source: secondary_id

SACI-IDD-00-27

Identifier Type: -

Identifier Source: secondary_id

UTHSC-0015011134

Identifier Type: -

Identifier Source: secondary_id

CDR0000068663

Identifier Type: -

Identifier Source: org_study_id