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A Phase II Trial of CPT-11 in Patients With Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Incorporating Pretreatment and Posttreatment Biopsies for Evaluation of Tumor Thymidylate Synthase, MIB-1, Topoisomerase I, and p53


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

A Phase II Trial of CPT-11 in Patients With Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Incorporating Pretreatment and Posttreatment Biopsies for Evaluation of Tumor Thymidylate Synthase, MIB-1, Topoisomerase I, and p53


OBJECTIVES: I. Evaluate the response rate, survival, and toxicity of previously untreated
patients with locally advanced or metastatic gastric cancer who are treated with irinotecan
(CPT-11).

OUTLINE: This is a nonrandomized study. Patients receive irinotecan (CPT-11) by IV over 90
minutes every 3 weeks. Dosage modifications are made based on toxicity. Retreatment may be
delayed another 3 weeks (for a total of 6 weeks) to allow for recovery from toxic effects.
Patient is taken off study if they do not recover from toxic effects, unless cause is
documented to be unrelated to CPT-11. Patients with stable disease or partial response
continue on treatment until disease progression or intolerable toxicity. Patients with
complete response continue on treatment for another 2 courses and then are observed.
Patients are followed every 3 months for 3 years or until disease progression.

PROJECTED ACCRUAL: A minimum of 21 and a maximum of 66 patients will be accrued into this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed advanced adenocarcinoma of the stomach
or gastroesophageal junction beyond hope of surgical cure and not considered a candidate
for potentially curative chemotherapy/radiation therapy Measurable or evaluable disease
Tumor must be accessible for biopsy No known central nervous system metastases or
carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
at least 150,000/mm3 Hemoglobin at least 9.0 mg/dL (transfusion allowed) Hepatic:
Bilirubin no greater than upper limit of normal (ULN), regardless of liver involvement
secondary to tumor AST no greater than 3 times ULN Renal: Creatinine no greater than 1.5
times ULN Cardiovascular: No unstable angina No uncontrolled high blood pressure No active
congestive heart failure No myocardial infarction in the last 6 months No serious
uncontrolled cardiac arrhythmia No New York Heart Association Class III or IV heart
disease Pulmonary: No interstitial pneumonia or extensive and symptomatic interstitial
fibrosis of the lung No pleural effusion or ascites, which cause respiratory compromise
(at least Grade 2 dyspnea) Other: No active or uncontrolled infection No prior malignancy,
except for adequately treated basal cell or squamous cell skin cancer, adequately treated
noninvasive carcinomas, or other cancer from which the patient has been disease free for
at least 5 years Not pregnant or nursing Adequate contraception required of all fertile
patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for gastric or gastroesophageal junction cancer No prior irinotecan (CPT-11)
or other camptothecin Endocrine therapy: Not specified Radiotherapy: No prior abdominal or
pelvic radiotherapy No prior radiotherapy to greater than 25% of bone marrow No prior
radiotherapy to measurable or evaluable indicator lesions At least 4 weeks since major
radiotherapy (chest radiotherapy) Surgery: At least 3 weeks since major surgery and
recovered At least 2 weeks since minor surgery and recovered Other: No other concurrent
investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard M. Goldberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000065905

NCT ID:

NCT00003137

Start Date:

December 1997

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage IV gastric cancer
  • stage IV esophageal cancer
  • adenocarcinoma of the esophagus
  • intestinal adenocarcinoma of the stomach
  • diffuse adenocarcinoma of the stomach
  • mixed adenocarcinoma of the stomach
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CentraCare ClinicSaint Cloud, Minnesota  56303
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Mayo Clinic JacksonvilleJacksonville, Florida  32224
Medcenter One Health SystemBismarck, North Dakota  58501