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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

Phase 2
18 Years
Not Enrolling
Esophageal Cancer, Gastric Cancer

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Trial Information

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


- 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

- 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

Inclusion Criteria


- 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

- 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

- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert L. DeJager, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Sankyo Inc.


United States: Federal Government

Study ID:




Start Date:

April 2001

Completion Date:

September 2003

Related Keywords:

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



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Cancer Therapy and Research Center San Antonio, Texas  78229
Pacific Shores Medical Group Long Beach, California  90813
Rocky Mountain Cancer Centers Thornton, Colorado  80260