Trial Outcomes & Findings for Docetaxel and Capecitabine With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (NCT NCT02524275)

Last Updated: 2023-09-08

Results Overview

The response rates of complete or partial response rate as defined by the Response Evaluation Criteria for Solid Tumors at 15 weeks of a chemotherapy regimen involving docetaxel and capecitabine as front line therapy at 95% confidence interval. Complete Response (CR): the disappearance of all target lesions Partial Response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

At 15 weeks

Results posted on

2023-09-08

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Docetaxel, Capecitabine) Patients receive docetaxel IV over 1 hour on day 1 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	14
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Docetaxel, Capecitabine) Patients receive docetaxel IV over 1 hour on day 1 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study not evaluable, completed less than 2 courses of chemotherapy.	5

Baseline Characteristics

Docetaxel and Capecitabine With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Docetaxel, Capecitabine) n=14 Participants Patients receive docetaxel IV over 1 hour on day 1 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	65.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	13 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
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: At 15 weeks

Outcome measures

Outcome measures
Measure	Treatment (Docetaxel, Capecitabine) n=14 Participants Patients receive docetaxel IV over 1 hour on day 1 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Docetaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Overall Response Rate of Complete or Partial Response	1 Participants

SECONDARY outcome

Timeframe: First date of therapy until the first notation of clinical progression, relapse or death from any cause, assessed up to 5 years

The Kaplan-Meier method will be used to estimate time to event distributions for progression-free survival. Progression-free survival will be defined as from the first date of therapy until the first notation of clinical progression, relapse or death from any cause.

Outcome measures

Outcome measures
Measure	Treatment (Docetaxel, Capecitabine) n=14 Participants Patients receive docetaxel IV over 1 hour on day 1 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Docetaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Progression-free Survival	211 days Interval 63.0 to 327.0

SECONDARY outcome

Timeframe: First date of therapy until the date of death from any cause, assessed up to 5 years

The Kaplan-Meier method will be used to estimate time to event distributions for survival. Survival will be defined as from the first date of therapy until the date of death from any cause.

Outcome measures

Outcome measures
Measure	Treatment (Docetaxel, Capecitabine) n=14 Participants Patients receive docetaxel IV over 1 hour on day 1 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Docetaxel: Given IV Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
Survival	264.5 days Interval 147.0 to 516.0

Adverse Events

Treatment (Docetaxel, Capecitabine)

Serious events: 10 serious events

Other events: 13 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Docetaxel, Capecitabine) n=14 participants at risk Patients receive docetaxel IV over 1 hour on day 1 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders febrile nuetropenia	35.7% 5/14 • Number of events 5 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Investigations White blood cell decreased	28.6% 4/14 • Number of events 4 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Gastrointestinal disorders dysphagia	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Gastrointestinal disorders Gastrointestinal disorder, Other	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Gastrointestinal disorders Mucositis, oral	14.3% 2/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Infections and infestations Abdominal infection	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Metabolism and nutrition disorders hypocalcemia	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Gastrointestinal disorders vomiting	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Investigations Neutrophil count decreased	14.3% 2/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Respiratory, thoracic and mediastinal disorders dyspnea	14.3% 2/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Infections and infestations Urinary tract infection	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Blood and lymphatic system disorders Anemia	14.3% 2/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Metabolism and nutrition disorders hypoglycemia	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
General disorders Non-cardiac chest pain	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders, Other	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Infections and infestations lung infection	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.

Other adverse events

Other adverse events
Measure	Treatment (Docetaxel, Capecitabine) n=14 participants at risk Patients receive docetaxel IV over 1 hour on day 1 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders colitis	100.0% 1/1 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Blood and lymphatic system disorders anemia	57.1% 8/14 • Number of events 12 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Gastrointestinal disorders diarrhea	35.7% 5/14 • Number of events 6 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
General disorders fatigue	21.4% 3/14 • Number of events 5 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Metabolism and nutrition disorders hypocalcemia	14.3% 2/14 • Number of events 4 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Metabolism and nutrition disorders hypophosphatemia	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Blood and lymphatic system disorders lymphocyte count decreased	21.4% 3/14 • Number of events 5 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Gastrointestinal disorders mucositis oral	42.9% 6/14 • Number of events 8 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Gastrointestinal disorders nausea	28.6% 4/14 • Number of events 5 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Blood and lymphatic system disorders neutrophil count decreased	14.3% 2/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Vascular disorders thromboembolic event	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Blood and lymphatic system disorders white blood cell decreased	14.3% 2/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Renal and urinary disorders acute kidney injury	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Skin and subcutaneous tissue disorders alopecia	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Psychiatric disorders anxiety	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Investigations aspartate aminotransferase increased	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Nervous system disorders ataxia	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Musculoskeletal and connective tissue disorders back pain	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Investigations blood bilirubin increased	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Gastrointestinal disorders constipation	14.3% 2/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Respiratory, thoracic and mediastinal disorders cough	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Investigations creatinine increased	14.3% 2/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Metabolism and nutrition disorders dehydration	14.3% 2/14 • Number of events 3 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Nervous system disorders dizziness	7.1% 1/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Gastrointestinal disorders dry mouth	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Gastrointestinal disorders dysphagia	14.3% 2/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Respiratory, thoracic and mediastinal disorders dyspnea	21.4% 3/14 • Number of events 3 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Endocrine disorders endocrine disorder - Other	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Respiratory, thoracic and mediastinal disorders epistaxis	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Skin and subcutaneous tissue disorders erythroderma	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Injury, poisoning and procedural complications fall	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Gastrointestinal disorders gastrointestinal disorder - Other	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Nervous system disorders headache	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Metabolism and nutrition disorders hypercalcemia	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Metabolism and nutrition disorders hyperglycemia	42.9% 6/14 • Number of events 8 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Metabolism and nutrition disorders hypoalbuminemia	50.0% 7/14 • Number of events 9 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Metabolism and nutrition disorders hypokalemia	28.6% 4/14 • Number of events 4 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Metabolism and nutrition disorders hypomagnesemia	14.3% 2/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Metabolism and nutrition disorders hyponatremia	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Vascular disorders hypotension	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Psychiatric disorders insomnia	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Investigations investigations - Other	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Investigations alkaline phosphatase increased	7.1% 1/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Metabolism and nutrition disorders metabolism and nutrition disorder - Other	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Musculoskeletal and connective tissue disorders musculoskeletal and connective tissue disorder - Other	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Musculoskeletal and connective tissue disorders myalgia	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Nervous system disorders nervous system disorder - Other	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
General disorders non-cardiac chest pain	14.3% 2/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Gastrointestinal disorders oral pain	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
General disorders pain	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Skin and subcutaneous tissue disorders palmar-plantar erythrodysesthesia syndrome	21.4% 3/14 • Number of events 5 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Cardiac disorders palpitations	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Nervous system disorders peripheral sensory neuropathy	7.1% 1/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Blood and lymphatic system disorders platelet count decreased	14.3% 2/14 • Number of events 2 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Skin and subcutaneous tissue disorders pruritus	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Skin and subcutaneous tissue disorders rash maculo-papular	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Renal and urinary disorders renal calculi	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Respiratory, thoracic and mediastinal disorders respiratory, thoracic and mediastinal disorder - Other	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Skin and subcutaneous tissue disorders skin and subcutaneous tissue disorder - Other	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Skin and subcutaneous tissue disorders skin hyperpigmentation	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Respiratory, thoracic and mediastinal disorders sore throat	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Gastrointestinal disorders stomach pain	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Nervous system disorders tremor	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Gastrointestinal disorders vomiting	21.4% 3/14 • Number of events 3 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.
Injury, poisoning and procedural complications wound dehiscence	7.1% 1/14 • Number of events 1 • Adverse Events will be collected from the time the subject starts the study drugs and ending 30 days following the final chemotherapy. Subjects with stable or responsive disease will continue on therapy until progression. For this study no subjects continued therapy beyond 12 months.

Additional Information

Dr. Apar Ganti

University of Nebraska Medical Center

Phone: 402-559-8121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place