DX-8951f in Treating Patients With Metastatic Stomach Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00017212
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 16, 2012
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

June 6, 2001
January 27, 2003
May 16, 2012
April 2001
September 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00017212 on Archive Site
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DX-8951f in Treating Patients With Metastatic Stomach Cancer
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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • Esophageal Cancer
  • Gastric Cancer
Drug: exatecan mesylate
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2003
September 2003   (Final data collection date for primary outcome measure)


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 9.0 g/dL


  • 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)


  • Creatinine no greater than 1.5 mg/dL


  • No active congestive heart failure
  • No uncontrolled angina
  • No myocardial infarction within the past 6 months


  • 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


  • See Disease Characteristics

Biologic therapy:

  • No concurrent anti-cancer biologic therapy
  • No concurrent prophylactic colony stimulating factors during first course of therapy


  • 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


  • 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


  • At least 4 weeks since prior major surgery and recovered
  • No concurrent anti-cancer surgery


  • No other investigational drugs (including analgesics or antiemetics) for at least 4 weeks prior to, during, and for 4 weeks after study
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc.
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Study Chair: Robert L. DeJager, MD, FACP Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP