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A Phase II Trial of 9-Aminocamptothecin (NSC 603071) Administered as a 120-Hour Continuous Infusion in Patients With Previously Untreated Gastric Cancer

Phase 2
18 Years
Not Enrolling
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

A Phase II Trial of 9-Aminocamptothecin (NSC 603071) Administered as a 120-Hour Continuous Infusion in Patients With Previously Untreated Gastric Cancer

OBJECTIVES: I. Determine the objective response rate of a 120 hour continuous infusion of
aminocamptothecin (9-AC) in chemotherapy naive patients with adenocarcinoma of the stomach
or gastroesophageal junction. II. Characterize the nature of the toxicity of 9-AC on this
schedule in this patient population. III. Determine the duration of response, time to
progression, and survival of this patient population. IV. Study the pharmacokinetics and
pharmacodynamics of 9-AC on this schedule in these patients.

OUTLINE: This is an open label, multicenter study. Patients receive intravenous
aminocamptothecin by continuous infusion over 120 hours on days 1-5 and 8-12 followed by 1
week of rest for a 3 week cycle. Therapy continues for a minimum of 6 weeks (2 full cycles)
unless there are unacceptable toxic effects or rapid disease progression. Dose escalation
may occur in patients who complete 3 cycles of therapy without unacceptable toxicity. All
patients will be followed for survival.

PROJECTED ACCRUAL: This study will accrue 14-40 patients within 18 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed, locally advanced, metastatic or
recurrent adenocarcinoma of the stomach or gastroesophageal junction Measurable disease
CNS metastases allowed provided that patient has other sites of measurable disease, is
neurologically stable, and is receiving no concurrent anticonvulsant therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3500/mm3 Absolute neutrophil count at least
1500/mm3 Platelet count at least 100,000/mm3 (no platelet transfusion within 7 days)
Hemoglobin at least 9 g/dL Hepatic: Total bilirubin no greater than 1.5 mg/dL
Transaminases no greater than 2.5 times upper limit of normal (ULN) (no greater than 5
times ULN if liver metastases) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine
clearance at least 60 mL/min Other: Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception No concurrent uncontrolled medical or
psychiatric condition No active uncontrolled infection No prior malignant disease within
the past 5 years except curatively treated non-melanoma skin cancer and carcinoma in situ
of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic growth factors
Chemotherapy: One prior adjuvant or neoadjuvant 5-FU-based chemotherapy regimen allowed At
least 4 weeks since prior adjuvant or neoadjuvant chemotherapy (6 weeks if nitrosoureas or
mitomycin) and recovered No prior therapy with a topoisomerase I inhibitor No other
concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: One prior
radiotherapy regimen allowed No prior radiation therapy to only site of measurable disease
At least 4 weeks since prior radiation therapy and recovered No concurrent palliative
radiation therapy Surgery: Not specified Other: See Disease Characteristics No other
concurrent investigational antineoplastic therapy

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate Objective response rate Objective response rate Objective response rate

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Hedy L. Kindler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

March 1998

Completion Date:

August 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
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



University of Chicago Cancer Research Center Chicago, Illinois  60637
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
Cancer Care Specialists of Central Illinois, S.C. Decatur, Illinois  62526
Oncology/Hematology Associates of Central Illinois, P.C. Peoria, Illinois  61602
Central Illinois Hematology Oncology Center Springfield, Illinois  62701
Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne, Indiana  46885-5099
Michiana Hematology/Oncology P.C. South Bend, Indiana  46617