DX-8951f in Treating Patients With Metastatic Stomach Cancer

May 15, 2012 updated by: Daiichi Sankyo, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Cancer Care Ontario-Hamilton Regional Cancer Centre
  • United States
    • California
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
    • Texas
      • Dallas, Texas, United States, 75235-9154
        • Simmons Cancer Center - Dallas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229-3264
        • Cancer Therapy and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

September 1, 2003

Study Completion (Actual)

September 1, 2003

Study Registration Dates

First Submitted

June 6, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

May 16, 2012

Last Update Submitted That Met QC Criteria

May 15, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068663
  • DAIICHI-8951A-PRT028
  • SACI-IDD-00-27
  • UTHSC-0015011134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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