DX-8951f in Treating Patients With Metastatic Stomach Cancer

Gastric Cancer Clinical Trial

Official title:

A Phase II Study Of Intravenous Exatecan Mesylate (DX-891F) Administered Daily For Five Days Every Three Weeks To Patients With Previously Untreated Metastatic Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00017212
• Other study ID #: CDR0000068663
• Secondary ID: DAIICHI-8951A-PR
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2001
• Last updated: May 15, 2012
• Start date: April 2001
• Est. completion date: September 2003

Study information

• Verified date: May 2012
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• exatecan mesylate

Locations

Country	Name	City	State
Canada	Cancer Care Ontario-Hamilton Regional Cancer Centre	Hamilton	Ontario
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Pacific Shores Medical Group	Long Beach	California
United States	Cancer Therapy and Research Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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 Dr — View Citation