NCT00003192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 1998

Longer than P75 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2002

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 30, 2004

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

3.9 years

First QC Date

November 1, 1999

Last Update Submit

September 4, 2013

Conditions

Esophageal CancerGastric Cancer

Keywords

stage III gastric cancerstage IV gastric cancerrecurrent gastric cancerstage III esophageal cancerstage IV esophageal cancerrecurrent esophageal canceradenocarcinoma of the stomach

Outcome Measures

Primary Outcomes (1)

  • Objective response rate Objective response rate Objective response rate Objective response rate

    4 years

Study Arms (1)

Arm A

EXPERIMENTAL

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

Drug: aminocamptothecin

Interventions

aminocamptothecinDRUG
Also known as: 9-AC
Arm A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Cancer Care Specialists of Central Illinois, S.C.

Decatur, Illinois, 62526, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61602, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62701, United States

Location

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, 46885-5099, United States

Location

Michiana Hematology/Oncology P.C.

South Bend, Indiana, 46617, United States

Location

MeSH Terms

Conditions

Esophageal NeoplasmsStomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Hedy L. Kindler, MD

    University of Chicago

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 30, 2004

Study Start

March 1, 1998

Primary Completion

February 1, 2002

Study Completion

August 1, 2003

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(7)