Trial Outcomes & Findings for S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer (NCT NCT00337129)
NCT ID: NCT00337129
Last Updated: 2015-08-25
Results Overview
Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Every 6 weeks until progression of disease up to a maximum of 3 years after registration
Results posted on
2015-08-25
Participant Flow
From June 2006 to December, 2007 a total of 42 patients were enrolled from SWOG institutions
2 patients are not eligible before assignment.
Participant milestones
| Measure |
Treatment (E7389 IV)
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
Treatment (E7389 IV)
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
32
|
|
Overall Study
Death
|
2
|
|
Overall Study
not protocol specified
|
1
|
Baseline Characteristics
S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Treatment (E7389 IV)
n=40 Participants
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
|
|---|---|
|
Age, Continuous
|
61 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks until progression of disease up to a maximum of 3 years after registrationPopulation: Only eligible patients were included in the analysis
Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.
Outcome measures
| Measure |
Treatment (E7389 IV)
n=40 Participants
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
|
|---|---|
|
Response Probability (Confirmed Complete and Partial Responses)
Complete Response
|
0 participants
|
|
Response Probability (Confirmed Complete and Partial Responses)
Partial Response
|
2 participants
|
|
Response Probability (Confirmed Complete and Partial Responses)
No Response
|
38 participants
|
SECONDARY outcome
Timeframe: Every 6 weeks until progression of disease up to a maximum of 3 years after registration.Progression-free survival was defined as the time from date of registration to the date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at date of last contact.
Outcome measures
| Measure |
Treatment (E7389 IV)
n=40 Participants
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
|
|---|---|
|
Progression-Free Survival
|
3 months
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration.Population: Only eligible patients were included in the analysis.
Overall survival was defined as the time from the date of registration to the date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Treatment (E7389 IV)
n=40 Participants
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
|
|---|---|
|
Overall Survival
|
7 months
Interval 5.0 to 10.0
|
SECONDARY outcome
Timeframe: Every 3 weeks while on protocol therapy, up to 3 years.Population: All eligible patients who started protocol treatment are included in analysis of toxicity
The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.
Outcome measures
| Measure |
Treatment (E7389 IV)
n=40 Participants
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
|
|---|---|
|
Participants With a Given Type of AE
Dehydration
|
1 participants
|
|
Participants With a Given Type of AE
Diarrhea
|
2 participants
|
|
Participants With a Given Type of AE
Dry mouth/salivary gland (xerostomia)
|
1 participants
|
|
Participants With a Given Type of AE
Dyspnea (shortness of breath)
|
2 participants
|
|
Participants With a Given Type of AE
Fatigue (asthenia, lethargy, malaise)
|
2 participants
|
|
Participants With a Given Type of AE
Glucose, serum-high (hyperglycemia)
|
1 participants
|
|
Participants With a Given Type of AE
Hemoglobin
|
1 participants
|
|
Participants With a Given Type of AE
Hemorrhage - Bronchopulmonary NOS
|
1 participants
|
|
Participants With a Given Type of AE
Infection w/ Grade 3/4 ANC - Skin (cellulitis)
|
1 participants
|
|
Participants With a Given Type of AE
Infection w unk ANC - gums (gingivitis)
|
1 participants
|
|
Participants With a Given Type of AE
Leukocytes (total WBC)
|
5 participants
|
|
Participants With a Given Type of AE
Lymphopenia
|
6 participants
|
|
Participants With a Given Type of AE
Mucositis - gums (gingivitis)
|
1 participants
|
|
Participants With a Given Type of AE
Neuropathy: sensory
|
1 participants
|
|
Participants With a Given Type of AE
Neutrophils/granulocytes (ANC/AGC)
|
4 participants
|
|
Participants With a Given Type of AE
Pneumonitis/pulmonary infiltrates
|
1 participants
|
|
Participants With a Given Type of AE
Potassium, serum-low (hypokalemia)
|
1 participants
|
|
Participants With a Given Type of AE
Sodium, serum-low (hyponatremia)
|
2 participants
|
Adverse Events
Treatment (E7389 IV)
Serious events: 5 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (E7389 IV)
n=40 participants at risk
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle. Includes only patients who received drug.
|
|---|---|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
2.5%
1/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade3 or 4 neutrophils-Skin(cellulitis)
|
2.5%
1/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Leukocytes (total WBC)
|
2.5%
1/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Lymphopenia
|
5.0%
2/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
2.5%
1/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Weight loss
|
2.5%
1/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS
|
2.5%
1/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
Other adverse events
| Measure |
Treatment (E7389 IV)
n=40 participants at risk
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle. Includes only patients who received drug.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
50.0%
20/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Constipation
|
12.5%
5/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Diarrhea
|
22.5%
9/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
5.0%
2/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
10.0%
4/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
5.0%
2/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Nausea
|
35.0%
14/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Pain - Oral cavity
|
5.0%
2/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
50.0%
20/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)
|
5.0%
2/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis)
|
5.0%
2/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
5.0%
2/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
10.0%
4/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Alkaline phosphatase
|
12.5%
5/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Leukocytes (total WBC)
|
27.5%
11/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Lymphopenia
|
22.5%
9/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
30.0%
12/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Platelets
|
5.0%
2/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Investigations
Weight loss
|
20.0%
8/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
15.0%
6/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
4/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
10.0%
4/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Dehydration
|
7.5%
3/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
15.0%
6/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
5.0%
2/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
10.0%
4/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
10.0%
4/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
5.0%
2/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Nervous system disorders
Neuropathy: sensory
|
12.5%
5/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Nervous system disorders
Pain - Head/headache
|
5.0%
2/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
7.5%
3/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
30.0%
12/40 • Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
|
Additional Information
Head and Neck Committtee Statistician
SWOG Statistical Center
Phone: (206)-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60