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DX-8951f in Treating Patients With Metastatic Stomach Cancer

Primary Purpose

Esophageal Cancer, Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
exatecan mesylate
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pacific Shores Medical Group
  • Rocky Mountain Cancer Centers
  • Simmons Cancer Center - Dallas
  • University of Texas - MD Anderson Cancer Center
  • Cancer Therapy and Research Center
  • Cancer Care Ontario-Hamilton Regional Cancer Centre

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
May 15, 2012
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00017212
Brief Title
DX-8951f in Treating Patients With Metastatic Stomach Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer
Keywords
stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
exatecan mesylate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. DeJager, MD, FACP
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Simmons Cancer Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9154
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Cancer Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3264
Country
United States
Facility Name
Cancer Care Ontario-Hamilton Regional Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16133799
Citation
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.
Results Reference
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DX-8951f in Treating Patients With Metastatic Stomach Cancer

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