Trial Outcomes & Findings for Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer (NCT NCT00130689)

Last Updated: 2015-05-14

Results Overview

Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 weeks (range 1-23 weeks).

Results posted on

2015-05-14

Participant Flow

Patients enrolled from September 2005 through November 2008.

Participant milestones

Participant milestones
Measure	Cetuximab Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
Overall Study STARTED	43
Overall Study Eligible	37
Overall Study Treated	35
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	43

Reasons for withdrawal

Reasons for withdrawal
Measure	Cetuximab Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
Overall Study Progressive Disease	29
Overall Study Death	1
Overall Study Clinical Deterioration	4
Overall Study Withdrawal by Subject	3
Overall Study Ineligible	6

Baseline Characteristics

Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetuximab n=35 Participants Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
Age, Customized	61 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants
Primary Tumor Esophagael	12 participants n=5 Participants
Primary Tumor GE Junction	8 participants n=5 Participants
Primary Tumor Gastric	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 weeks (range 1-23 weeks).

Population: Responses were determined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Cetuximab n=35 Participants Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
Overall Response Rate	0.029 proportion of paticipants Interval 0.0014 to 0.128

Adverse Events

Cetuximab

Serious events: 5 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cetuximab n=35 participants at risk Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Hemoglobin	2.9% 1/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Blood and lymphatic system disorders Lymphocytes	2.9% 1/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Fatigue	5.7% 2/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Headache	2.9% 1/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Nausea	2.9% 1/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Acneiform Rash	2.9% 1/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Pruritis/itching	2.9% 1/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.

Other adverse events

Other adverse events
Measure	Cetuximab n=35 participants at risk Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Hemoglobin	45.7% 16/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Blood and lymphatic system disorders Leukocytes	11.4% 4/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Blood and lymphatic system disorders Lymphocytes	20.0% 7/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Blood and lymphatic system disorders Platelets	2.9% 1/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypomagnesemia	40.0% 14/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hyperglycemia	22.9% 8/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Aspartate aminotransferase	14.3% 5/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Alanine aminotransferase	11.4% 4/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Alkaline phosphatase	14.3% 5/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hyponatremia	11.4% 4/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypokalemia	2.9% 1/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypoalbuminemia	11.4% 4/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Renal and urinary disorders Bilirubin	2.9% 1/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Abdominal pain	17.1% 6/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Chest pain	5.7% 2/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Hypersensitivity reaction	2.9% 1/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Alopecia	14.3% 5/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Anorexia	40.0% 14/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Constipation	25.7% 9/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Respiratory, thoracic and mediastinal disorders Cough	5.7% 2/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Dehydration	11.4% 4/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Diarrhea	20.0% 7/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Dry skin	17.1% 6/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.7% 2/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Fatigue	57.1% 20/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Fever	17.1% 6/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Headache	11.4% 4/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Mucositis	11.4% 4/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Nail changes	5.7% 2/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Nausea	34.3% 12/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Nervous system disorders Sensory neuropathy	5.7% 2/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Acneiform rash	74.3% 26/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Vomiting	22.9% 8/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Weight loss	11.4% 4/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
General disorders Rigors/chills	5.7% 2/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Pruritis/itching	2.9% 1/35 • Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.

Additional Information

Jennifer Ang Chan, MD, MPH

Dana-Farber Cancer Institute

Phone: 617-632-6315

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place