DX-8951f in Treating Patients With Metastatic Stomach Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00017212
First received: June 6, 2001
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: exatecan mesylate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Study Start Date: April 2001
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017212

Locations
United States, California
Pacific Shores Medical Group
Long Beach, California, United States, 90813
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229-3264
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
Study Chair: Robert L. DeJager, MD, FACP Daiichi Sankyo Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00017212     History of Changes
Other Study ID Numbers: CDR0000068663, DAIICHI-8951A-PRT028, SACI-IDD-00-27, UTHSC-0015011134
Study First Received: June 6, 2001
Last Updated: May 15, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
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

Additional relevant MeSH terms:
Esophageal Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Exatecan
Camptothecin
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 29, 2014