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Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00006046
Recruitment Status : Terminated (poor recruitment)
First Posted : May 21, 2003
Results First Posted : August 9, 2021
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Intervention Biological: monoclonal antibody hu3S193
Enrollment 7
Recruitment Details Seven patients were entered into the 10mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
Pre-assignment Details  
Arm/Group Title Hu3S193 10 mg/m2 Hu3S193 25 mg/m2 Hu3S193 50 mg/m2 Hu3S193 100 mg/m2 Hu3S193 200 mg/m2
Hide Arm/Group Description Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression. Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression. Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression. Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression. Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
Period Title: Overall Study
Started 7 0 0 0 0
Completed 2 0 0 0 0
Not Completed 5 0 0 0 0
Reason Not Completed
Adverse Event             3             0             0             0             0
Disease Progression             2             0             0             0             0
Arm/Group Title Hu3S193 10 mg/m2 Hu3S193 25 mg/m2 Hu3S193 50 mg/m2 Hu3S193 100 mg/m2 Hu3S193 200 mg/m2 Total
Hide Arm/Group Description Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression. Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression. Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression. Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression. Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression. Total of all reporting groups
Overall Number of Baseline Participants 7 0 0 0 0 7
Hide Baseline Analysis Population Description
All patients entered into the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 0 participants 0 participants 0 participants 0 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  85.7%
6
  85.7%
>=65 years
1
  14.3%
1
  14.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 0 participants 0 participants 0 participants 0 participants 7 participants
Female
4
  57.1%
4
  57.1%
Male
3
  42.9%
3
  42.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 0 participants 0 participants 0 participants 0 participants 7 participants
Hispanic or Latino
2
  28.6%
2
  28.6%
Not Hispanic or Latino
5
  71.4%
5
  71.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 0 participants 0 participants 0 participants 0 participants 7 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
White
7
 100.0%
7
 100.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 0 participants 0 participants 0 participants 0 participants 7 participants
7 7
1.Primary Outcome
Title Number of Patients With Dose-limiting Toxicities (DLTs)
Hide Description Toxicity was graded in accordance with the Common Toxicity Scale developed by NCI (1998) where Grade 1 represents the lowest toxicity grade and Grade 5 death. Dose-limiting toxicity (DLT) was defined as Grade 3 and Grade 4 adverse events which were at least possibly related to study treatment.
Time Frame up to 10 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who entered the study.
Arm/Group Title Hu3S193 10 mg/m2 Hu3S193 25 mg/m2 Hu3S193 50 mg/m2 Hu3S193 100 mg/m2 Hu3S193 200 mg/m2
Hide Arm/Group Description:
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
Overall Number of Participants Analyzed 7 0 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
1
  14.3%
0 0 0 0
2.Secondary Outcome
Title Number of Patients With Tumor Responses
Hide Description Complete response (CR); disappearance of all measurable disease lasting a minimum of 4 weeks. Partial Response (PR); 50% or greater decrease in the sum of the products of the perpendicular diameters or all measurable lesions, without development of new lesions or increase in size of any lesion, lasting a minimum of 4 weeks. Progressive disease (PD); Appearance of new lesions or increase by 25% or more in size of any measurable lesion. Stable disease (SD); Not meeting criteria for response or progression.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who entered the study and had tumor assessments.
Arm/Group Title Hu3S193 10 mg/m2 Hu3S193 25 mg/m2 Hu3S193 50 mg/m2 Hu3S193 100 mg/m2 Hu3S193 200 mg/m2
Hide Arm/Group Description:
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
Overall Number of Participants Analyzed 4 0 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
CR
0
   0.0%
0 0 0 0
PR
0
   0.0%
0 0 0 0
SD
0
   0.0%
0 0 0 0
PD
4
 100.0%
0 0 0 0
Time Frame up to 10 weeks
Adverse Event Reporting Description

Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998).

Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.

 
Arm/Group Title Hu3S193 10 mg/m2 Hu3S193 25 mg/m2 Hu3S193 50 mg/m2 Hu3S193 100 mg/m2 Hu3S193 200 mg/m2
Hide Arm/Group Description Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression. Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression. Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression. Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression. Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
All-Cause Mortality
Hu3S193 10 mg/m2 Hu3S193 25 mg/m2 Hu3S193 50 mg/m2 Hu3S193 100 mg/m2 Hu3S193 200 mg/m2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/0   0/0   0/0   0/0 
Hide Serious Adverse Events
Hu3S193 10 mg/m2 Hu3S193 25 mg/m2 Hu3S193 50 mg/m2 Hu3S193 100 mg/m2 Hu3S193 200 mg/m2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/7 (71.43%)   0/0   0/0   0/0   0/0 
Blood and lymphatic system disorders           
Neutropenia  1  1/7 (14.29%)  0/0  0/0  0/0  0/0 
Gastrointestinal disorders           
Rectal hemorrhage  1  1/7 (14.29%)  0/0  0/0  0/0  0/0 
Infections and infestations           
Actinomycosis  1  1/7 (14.29%)  0/0  0/0  0/0  0/0 
Musculoskeletal and connective tissue disorders           
Back pain  1  2/7 (28.57%)  0/0  0/0  0/0  0/0 
1
Term from vocabulary, MedDRA 24
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hu3S193 10 mg/m2 Hu3S193 25 mg/m2 Hu3S193 50 mg/m2 Hu3S193 100 mg/m2 Hu3S193 200 mg/m2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/7 (42.86%)   0/0   0/0   0/0   0/0 
Gastrointestinal disorders           
Dyspepsia  1  1/7 (14.29%)  0/0  0/0  0/0  0/0 
Nausea  1  1/7 (14.29%)  0/0  0/0  0/0  0/0 
Vomiting  1  1/7 (14.29%)  0/0  0/0  0/0  0/0 
General disorders           
Pyrexia  1  1/7 (14.29%)  0/0  0/0  0/0  0/0 
Infections and infestations           
Viral infection  1  1/7 (14.29%)  0/0  0/0  0/0  0/0 
Musculoskeletal and connective tissue disorders           
Back pain  1  1/7 (14.29%)  0/0  0/0  0/0  0/0 
Chills  1  1/7 (14.29%)  0/0  0/0  0/0  0/0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Tumor hemorrhage  1  1/7 (14.29%)  0/0  0/0  0/0  0/0 
1
Term from vocabulary, MedDRA 24
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mary Macri, Senior Director, Clinical Trials Management
Organization: Ludwig Institute for Cancer Research
Phone: 12124501546
EMail: mmacri@lcr.org
Layout table for additonal information
Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00006046    
Other Study ID Numbers: CDR0000068062
MSKCC-00005 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
LUD1999-007 ( Other Identifier: Ludwig Institute for Cancer Research )
First Submitted: July 5, 2000
First Posted: May 21, 2003
Results First Submitted: July 15, 2021
Results First Posted: August 9, 2021
Last Update Posted: August 9, 2021