NCT00003543

Brief Summary

RATIONALE: Monoclonal antibodies can find and locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy plus combination chemotherapy in treating patients with advanced colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 colorectal-cancer

Timeline
Completed

Started Jun 1998

Typical duration for phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

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

June 1, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
2 years until next milestone

First Posted

Study publicly available on registry

August 16, 2004

Completed
Last Updated

June 27, 2013

Status Verified

June 1, 2013

Enrollment Period

4.2 years

First QC Date

November 1, 1999

Last Update Submit

June 25, 2013

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancer

Interventions

monoclonal antibody A33BIOLOGICAL
carmustineDRUG
fluorouracilDRUG
streptozocinDRUG
vincristine sulfateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed unresectable stage IV colon or rectal cancer that has failed conventional chemotherapy for advanced disease or refused other treatment Measurable disease No liver involvement of greater than 50% No clinical evidence of CNS tumor involvement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: At least 14 weeks Hematopoietic: WBC at least 3,5000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.0 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No clinically significant cardiac disease (New York Heart Association class III/IV heart disease) Other: No positive human antimouse antibody titer No serious infection requiring treatment with antibiotics No other serious illness Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No prior mouse monoclonal antibody or antibody fragment, or chimeric or humanized antibody At least 4 weeks since prior immunotherapy Chemotherapy: No prior carmustine, fluorouracil, vincristine, and streptozocin At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

CarmustineFluorouracilStreptozocinVincristine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAminoglycosidesGlycosidesCarbohydratesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Sydney Welt, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 16, 2004

Study Start

June 1, 1998

Primary Completion

August 1, 2002

Study Completion

August 1, 2002

Last Updated

June 27, 2013

Record last verified: 2013-06

Locations

US(1)