Trial Outcomes & Findings for S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer (NCT NCT00096031)

NCT ID: NCT00096031

Last Updated: 2018-09-26

Results Overview

Time to death is measured from date of registration to date of death due to any cause.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 63 participants
• Primary outcome timeframe: every 3 weeks while on treatment, then every 3 months
• Results posted on: 2018-09-26

Participant Flow

Participant milestones

Measure	Cetuximab 250 mg/m\^2 on days 1, 8, 15, and 22 of every 28-day cycle.
Overall Study STARTED	63
Overall Study Eligible	57
Overall Study Eligible and Began Protocol Therapy	55
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	63

Reasons for withdrawal

Measure	Cetuximab 250 mg/m\^2 on days 1, 8, 15, and 22 of every 28-day cycle.
Overall Study Adverse Event	3
Overall Study Lack of Efficacy	42
Overall Study Death	4
Overall Study Withdrawal by Subject	1
Overall Study Ineligible	8
Overall Study Not protocol specified	5

Baseline Characteristics

S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

Baseline characteristics by cohort

Measure	Cetuximab n=55 Participants 250 mg/m\^2 on days 1, 8, 15, and 22 of every 28-day cycle.
Age, Continuous	61.2 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: every 3 weeks while on treatment, then every 3 months

Time to death is measured from date of registration to date of death due to any cause.

Outcome measures

Measure	Cetuximab n=55 Participants 250 mg/m\^2 on days 1, 8, 15, and 22 of every 28-day cycle.
Overall Survival at 6 Months	36 percentage of participants Interval 24.0 to 50.0

SECONDARY outcome

Timeframe: every 3 weeks while on treatment

Time to treatment failure is measured from date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment. Progressive disease is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

Outcome measures

Measure	Cetuximab n=55 Participants 250 mg/m\^2 on days 1, 8, 15, and 22 of every 28-day cycle.
Time to Treatment Failure	1.8 months Interval 1.7 to 1.9

SECONDARY outcome

Timeframe: every 3 weeks while on treatment, then every 3 months for 3 years

Progression free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progressive disease is defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

Outcome measures

Measure	Cetuximab n=55 Participants 250 mg/m\^2 on days 1, 8, 15, and 22 of every 28-day cycle.
Time to Progression	1.8 months Interval 1.7 to 1.9

Adverse Events

Cetuximab

Serious events: 1 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cetuximab n=55 participants at risk
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	1.8% 1/55 • After every 28 days while on treatment Standard AE form

Other adverse events

Measure	Cetuximab n=55 participants at risk
Blood and lymphatic system disorders Hemoglobin	45.5% 25/55 • After every 28 days while on treatment Standard AE form
Gastrointestinal disorders Constipation	9.1% 5/55 • After every 28 days while on treatment Standard AE form
Gastrointestinal disorders Diarrhea	12.7% 7/55 • After every 28 days while on treatment Standard AE form
Gastrointestinal disorders Heartburn/dyspepsia	9.1% 5/55 • After every 28 days while on treatment Standard AE form
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	5.5% 3/55 • After every 28 days while on treatment Standard AE form
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic) - Oral cavity	5.5% 3/55 • After every 28 days while on treatment Standard AE form
Gastrointestinal disorders Nausea	41.8% 23/55 • After every 28 days while on treatment Standard AE form
Gastrointestinal disorders Pain - Abdomen NOS	12.7% 7/55 • After every 28 days while on treatment Standard AE form
Gastrointestinal disorders Vomiting	18.2% 10/55 • After every 28 days while on treatment Standard AE form
General disorders Fatigue (asthenia, lethargy, malaise)	61.8% 34/55 • After every 28 days while on treatment Standard AE form
General disorders Rigors/chills	5.5% 3/55 • After every 28 days while on treatment Standard AE form
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	5.5% 3/55 • After every 28 days while on treatment Standard AE form
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	5.5% 3/55 • After every 28 days while on treatment Standard AE form
Investigations AST, SGOT (serum glutamic oxaloacetic transaminase)	7.3% 4/55 • After every 28 days while on treatment Standard AE form
Investigations Alkaline phosphatase	12.7% 7/55 • After every 28 days while on treatment Standard AE form
Investigations Bilirubin (hyperbilirubinemia)	7.3% 4/55 • After every 28 days while on treatment Standard AE form
Investigations Leukocytes (total WBC)	5.5% 3/55 • After every 28 days while on treatment Standard AE form
Investigations Platelets	5.5% 3/55 • After every 28 days while on treatment Standard AE form
Investigations Weight loss	10.9% 6/55 • After every 28 days while on treatment Standard AE form
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	5.5% 3/55 • After every 28 days while on treatment Standard AE form
Metabolism and nutrition disorders Anorexia	20.0% 11/55 • After every 28 days while on treatment Standard AE form
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	7.3% 4/55 • After every 28 days while on treatment Standard AE form
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	7.3% 4/55 • After every 28 days while on treatment Standard AE form
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	16.4% 9/55 • After every 28 days while on treatment Standard AE form
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	7.3% 4/55 • After every 28 days while on treatment Standard AE form
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	7.3% 4/55 • After every 28 days while on treatment Standard AE form
Nervous system disorders Pain - Head/headache	14.5% 8/55 • After every 28 days while on treatment Standard AE form
Nervous system disorders Taste alteration (dysgeusia)	7.3% 4/55 • After every 28 days while on treatment Standard AE form
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	9.1% 5/55 • After every 28 days while on treatment Standard AE form
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (clinical exam) - Pharynx	5.5% 3/55 • After every 28 days while on treatment Standard AE form
Skin and subcutaneous tissue disorders Dry skin	16.4% 9/55 • After every 28 days while on treatment Standard AE form
Skin and subcutaneous tissue disorders Nail changes	5.5% 3/55 • After every 28 days while on treatment Standard AE form
Skin and subcutaneous tissue disorders Pruritus/itching	12.7% 7/55 • After every 28 days while on treatment Standard AE form
Skin and subcutaneous tissue disorders Rash/desquamation	10.9% 6/55 • After every 28 days while on treatment Standard AE form
Skin and subcutaneous tissue disorders Rash: acne/acneiform	70.9% 39/55 • After every 28 days while on treatment Standard AE form

Additional Information

Study Statistician

SWOG Statistical Center

Phone: 206-667-4623

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place