Trial Outcomes & Findings for Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE) (NCT NCT00599131)
NCT ID: NCT00599131
Last Updated: 2015-12-03
Results Overview
The proportion of patients treated with radiation+cetuximab achieving histologic CR will be estimated, along with 95% exact confidence intervals. Histologic Complete Response (CR) will be defined as primary tumors exhibiting a clinical CR or at least a 90% PR (Partial Response) along with a negative post-treatment biopsy.
TERMINATED
PHASE2
4 participants
3 years
2015-12-03
Participant Flow
Participant milestones
| Measure |
Chemotherapy/Radiation/Surgery
Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.
On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.
Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)
Baseline characteristics by cohort
| Measure |
Chemotherapy/Radiation/Surgery
n=4 Participants
Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.
On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.
Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.
|
|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The study was discontinued prematurely due to an early stopping rule. No participants were assessed for the primary outcome because an insufficient number of patients were recruited.
The proportion of patients treated with radiation+cetuximab achieving histologic CR will be estimated, along with 95% exact confidence intervals. Histologic Complete Response (CR) will be defined as primary tumors exhibiting a clinical CR or at least a 90% PR (Partial Response) along with a negative post-treatment biopsy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 23Population: The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.
To determine tumor EGFR degradation, as well as other markers of down-stream EGFR inhibition, observed in tumor biopsies taken shortly after the administration of cetuximab following TPF, compared with pre-treatment biopsies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsPopulation: The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.
To evaluate the quality of life (QOL).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.
To determine the overall survival rates compared to the overall survival rates of historical controls.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 years.Population: The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.
To determine and compare toxicities, most notably mucositis and dysphagia, in patients on this treatment regimen as compared to historical controls.
Outcome measures
Outcome data not reported
Adverse Events
Chemotherapy/Radiation/Surgery
Serious adverse events
| Measure |
Chemotherapy/Radiation/Surgery
n=4 participants at risk
Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.
On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.
Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.
|
|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Colitis, Infection
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
Infection with Grade 3-4 Neutrophils
|
25.0%
1/4 • Number of events 1
|
Other adverse events
| Measure |
Chemotherapy/Radiation/Surgery
n=4 participants at risk
Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.
On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.
Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.
|
|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
50.0%
2/4 • Number of events 2
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 2
|
|
General disorders
Weight loss
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
75.0%
3/4 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation
|
100.0%
4/4 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
25.0%
1/4 • Number of events 2
|
|
Gastrointestinal disorders
Anorexia
|
100.0%
4/4 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 3
|
|
Gastrointestinal disorders
Dehydration
|
75.0%
3/4 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
25.0%
1/4 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
100.0%
4/4 • Number of events 8
|
|
Gastrointestinal disorders
Esophagitis
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Mucositis/stomatitis (clinical exam), Oral Cavity
|
75.0%
3/4 • Number of events 9
|
|
Investigations
Mucositis/stomatitis (clinical exam), Pharynx
|
75.0%
3/4 • Number of events 7
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic), Oral Cavity
|
50.0%
2/4 • Number of events 5
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic), Pharynx
|
25.0%
1/4 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
Febrile neutropenia
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Infection with Grade 3 or 4 neutrophils
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Foreign Body)
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Infection (Upper Aerodigestive, NOS)
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Infection (Upper Airway, NOS)
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Infection with unknown ANC (Upper Aerodigestive)
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, Extremity-lower
|
25.0%
1/4 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, Whole body/generalized
|
50.0%
2/4 • Number of events 3
|
|
Nervous system disorders
Confusion
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Mood alteration
|
50.0%
2/4 • Number of events 2
|
|
Eye disorders
Ocular/Visual - Other (Specify)
|
25.0%
1/4 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
25.0%
1/4 • Number of events 1
|
|
Cardiac disorders
Chest Pain
|
50.0%
2/4 • Number of events 2
|
|
Nervous system disorders
Head Pain
|
50.0%
2/4 • Number of events 2
|
|
Gastrointestinal disorders
Oral Pain
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Throat Pain
|
75.0%
3/4 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
50.0%
2/4 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Fistula, pulmonary/upper respiratory
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify)
|
25.0%
1/4 • Number of events 1
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function - Other (Specify)
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
75.0%
3/4 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
2/4 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
2/4 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
4/4 • Number of events 12
|
Additional Information
Dr. Francis Worden
University of Michigan Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place