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Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus

Primary Purpose

Esophageal Cancer, Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aminocamptothecin
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Cancer Research Center
  • Louis A. Weiss Memorial Hospital
  • Cancer Care Specialists of Central Illinois, S.C.
  • Oncology/Hematology Associates of Central Illinois, P.C.
  • Central Illinois Hematology Oncology Center
  • Fort Wayne Medical Oncology and Hematology, Inc.
  • Michiana Hematology/Oncology P.C.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

9-aminocamptothecin (25 mcg/m2/hr x 120hrs, days 1-5 and 8-12 of each 3 week cycle)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
September 4, 2013
Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003192
Brief Title
Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus
Official Title
A Phase II Trial of 9-Aminocamptothecin (NSC 603071) Administered as a 120-Hour Continuous Infusion in Patients With Previously Untreated Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 aminocamptothecin in treating patients with locally advanced, metastatic, or recurrent cancer of the stomach or esophagus.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
9-aminocamptothecin (25 mcg/m2/hr x 120hrs, days 1-5 and 8-12 of each 3 week cycle)
Intervention Type
Drug
Intervention Name(s)
aminocamptothecin
Other Intervention Name(s)
9-AC
Primary Outcome Measure Information:
Title
Objective response rate Objective response rate Objective response rate Objective response rate
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hedy L. Kindler, MD
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Cancer Care Specialists of Central Illinois, S.C.
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Oncology/Hematology Associates of Central Illinois, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
Michiana Hematology/Oncology P.C.
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States

12. IPD Sharing Statement

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Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus

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