NCT00002664

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood, and may help a person's immune system kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus G-CSF in treating patients with metastatic colorectal cancer that has not responded to treatment with fluorouracil.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 1995

Longer than P75 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 1, 1995

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

May 24, 2004

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

21.7 years

First QC Date

November 1, 1999

Last Update Submit

July 10, 2017

Conditions

Colorectal Cancer

Keywords

recurrent colon cancerrecurrent rectal cancer

Study Arms (1)

Treatment

EXPERIMENTAL
Biological: edrecolomabBiological: sargramostim

Interventions

edrecolomabBIOLOGICAL
Treatment
sargramostimBIOLOGICAL
Treatment

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed carcinoma of the colon or rectum with radiologically confirmed metastases or clinically confirmed incurability No hepatic or CNS metastases Progression following fluorouracil (5-FU) alone or with a modulator (e.g., leucovorin, PALA, levamisole, interferon) Measurable disease outside prior radiotherapy fields The following are not considered measurable: Pleural effusion or ascites Osteoblastic lesions or evidence of disease on bone scan alone Progressive irradiated lesions alone Bone marrow involvement Brain metastases Malignant hepatomegaly by physical exam alone Chemical markers (e.g., CEA) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 16 weeks Hematopoietic: Absolute neutrophil count at least 1,800/mm3 Platelet count at least 125,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Other: No concurrent infection Afebrile for at least 3 days prior to treatment unless fever due to tumor No known HIV infection No other medical condition that precludes protocol participation No second malignancy within 5 years except: Nonmelanomatous skin cancer Curatively treated in situ cervical carcinoma No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women Blood/body fluid analyses within 7 days prior to registration Imaging/exams for tumor measurement within 21 days prior to registration PRIOR CONCURRENT THERAPY: Biologic therapy: No prior mouse-based vaccines or monoclonal antibodies Chemotherapy: At least 2 weeks since prior 5-FU or at least 1 week past the AGC nadir, whichever is later No other prior chemotherapy except irinotecan Endocrine therapy: Not specified Radiotherapy: At least 6 months since 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)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Edrecolomabsargramostim

Condition Hierarchy (Ancestors)

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

Study Officials

  • James D. Ahlgren, MD

    George Washington University

    STUDY CHAIR
0

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 24, 2004

Study Start

July 1, 1995

Primary Completion

February 22, 2017

Study Completion

February 22, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

US(1)