Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

• ClinicalTrials.gov Identifier: NCT00006046
• Recruitment Status: Terminated
• First Posted: May 21, 2003
• Results First Posted: August 9, 2021
• Last Update Posted: August 9, 2021
• Sponsor: Ludwig Institute for Cancer Research
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Hu3S193 10 mg/m2	Hu3S193 25 mg/m2	Hu3S193 50 mg/m2	Hu3S193 100 mg/m2	Hu3S193 200 mg/m2	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Dose-limiting Toxicities (DLTs)
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.

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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

Adverse Events

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
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
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Mary Macri, Senior Director, Clinical Trials Management
• Organization: Ludwig Institute for Cancer Research
• Phone: 12124501546
• EMail: mmacri@lcr.org

• 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