Clinical trial NCT00017212: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Dallas
country: United States
facility: Simmons Cancer Center - Dallas
state: Texas
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center
state: Texas
city: Hamilton
country: Canada
facility: Cancer Care Ontario-Hamilton Regional Cancer Centre
state: Ontario
Study officials:
affiliation: Daiichi Sankyo
name: Robert L. DeJager, MD, FACP
role: STUDY_CHAIR
References:
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.