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Trial · Interventional

TerminatedPhase 2Registry data

Chemotherapy Plus IM-862 in Treating Patients With Metastatic Colorectal Cancer

NCTNCT00006037 (opens ClinicalTrials.gov in a new tab)Other idCDR0000068052 (3C-99-3)Other idLAC-USC-3C993Other idNCI-G00-1812
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Overview

Status
Terminated
Phase
Phase 2
Enrollment
18 participants (actual)
Sponsor
University of Southern California · Other
Design
Not stated
Countries
1 country

United States

Start
Nov 1999
Primary completion
Nov 2001
Completion
Nov 2001
First posted
26 Feb 2004 (estimated)
Last update posted
22 May 2014 (estimated)
Conditions
Colorectal Cancer

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
1999200020012002
  1. Ph 2

    Chemotherapy Plus IM-862 in Treating Patients With Metastatic Colorectal Cancer

    NCT00006037

    Nov 1999 to Nov 2001

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may stop the growth of colorectal cancer by stopping blood flow to the tumor. It is not yet known if chemotherapy is more effective with or without IM-862 in treating colorectal cancer. PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy plus IM-862 in treating patients who have metastatic colorectal cancer.

Interventions

  • fluorouracilDrug
  • irinotecan hydrochlorideDrug
  • oglufanide disodiumDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes0

Outcomes the sponsor listed as primary.

The registry lists no primary outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the colon or rectum Previously untreated OR Recurrent with a disease free period of at least 1 year Measurable or evaluable disease Tumor must be accessible for biopsy No brain metastasis PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) (no greater than 3 times ULN if liver metastasis present) AST or ALT no greater than 2 times ULN (no greater than 5 times ULN if liver metastasis present) Renal: Creatinine no greater than 1.25 times ULN Cardiovascular: No myocardial infarction within the past year No congestive heart failure Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 6 months after study No medical, social, or psychological factor that would interfere with compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Prior adjuvant immunotherapy with monoclonal antibody 17-1A allowed No prior IM-862 Chemotherapy: At least 1 year since prior chemotherapy for patients with recurrent metastatic adenocarcinoma of the colon or rectum Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: Not specified

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