Trial Outcomes & Findings for A Study of Docetaxel in Combination With Capecitabine in Stomach and Esophagus Cancers (NCT NCT00177255)
NCT ID: NCT00177255
Last Updated: 2016-02-08
Results Overview
The time interval between the date on which a patient first received protocol treatment and the documented date of death.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
2 years
Results posted on
2016-02-08
Participant Flow
Participant milestones
| Measure |
Docetaxel + Capecitabine
Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.
Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Docetaxel in Combination With Capecitabine in Stomach and Esophagus Cancers
Baseline characteristics by cohort
| Measure |
Docetaxel + Capecitabine
n=39 Participants
Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.
Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe time interval between the date on which a patient first received protocol treatment and the documented date of death.
Outcome measures
| Measure |
Docetaxel + Capecitabine
n=39 Participants
Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.
Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
|
|---|---|
|
Overall Survival
|
10.7 Months
Interval 6.8 to 12.1
|
SECONDARY outcome
Timeframe: Every 2 cycles (6 weeks)The number of responders (complete responders + partial responders) divided by the number of evaluable patients.
Outcome measures
| Measure |
Docetaxel + Capecitabine
n=39 Participants
Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.
Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
|
|---|---|
|
Overall Response Rate
|
28.2 percentage of participants
Interval 15.0 to 44.9
|
Adverse Events
Docetaxel + Capecitabine
Serious events: 20 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel + Capecitabine
n=39 participants at risk
Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.
Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
|
|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow-Other
|
2.6%
1/39
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
2.6%
1/39
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.6%
1/39
|
|
Vascular disorders
Hypotension
|
2.6%
1/39
|
|
Cardiac disorders
Cardiovascular/General-Other
|
5.1%
2/39
|
|
Vascular disorders
Thrombosis/Embolism
|
2.6%
1/39
|
|
General disorders
Constitutional Symptoms-Other
|
15.4%
6/39
|
|
Metabolism and nutrition disorders
Anorexia
|
2.6%
1/39
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/39
|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
10.3%
4/39
|
|
Gastrointestinal disorders
Colitis
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
1/39
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
2.6%
1/39
|
|
Eye disorders
Ocular/Visual-Other
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other
|
10.3%
4/39
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.6%
1/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
|
2.6%
1/39
|
|
Nervous system disorders
Dizziness
|
2.6%
1/39
|
Other adverse events
| Measure |
Docetaxel + Capecitabine
n=39 participants at risk
Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.
Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
2.6%
1/39
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
5.1%
2/39
|
|
Metabolism and nutrition disorders
Anorexia
|
35.9%
14/39
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
2.6%
1/39
|
|
Gastrointestinal disorders
Constipation
|
25.6%
10/39
|
|
General disorders
Constitutional Symptoms - Other
|
5.1%
2/39
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.8%
5/39
|
|
Metabolism and nutrition disorders
Dehydration
|
12.8%
5/39
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
12.8%
5/39
|
|
Gastrointestinal disorders
Diarrhea
|
41.0%
16/39
|
|
Nervous system disorders
Dizziness
|
10.3%
4/39
|
|
Eye disorders
Dry eye syndrome
|
2.6%
1/39
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.1%
2/39
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
12.8%
5/39
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
23.1%
9/39
|
|
General disorders
Edema: head and neck
|
5.1%
2/39
|
|
General disorders
Edema: limb
|
23.1%
9/39
|
|
General disorders
Edema: trunk/genital
|
5.1%
2/39
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
66.7%
26/39
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
7.7%
3/39
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
3/39
|
|
Vascular disorders
Flushing
|
10.3%
4/39
|
|
Injury, poisoning and procedural complications
Fracture
|
2.6%
1/39
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
7.7%
3/39
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
10.3%
4/39
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
15.4%
6/39
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
12.8%
5/39
|
|
Blood and lymphatic system disorders
Hemoglobin
|
35.9%
14/39
|
|
Gastrointestinal disorders
Hemorrhage, GI, Lower GI NOS
|
2.6%
1/39
|
|
Gastrointestinal disorders
Hemorrhage, GI, Rectum
|
5.1%
2/39
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding - Other
|
7.7%
3/39
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
2.6%
1/39
|
|
Vascular disorders
Hypotension
|
5.1%
2/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Sinus
|
2.6%
1/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS
|
2.6%
1/39
|
|
General disorders
Injection site reaction/extravasation changes
|
2.6%
1/39
|
|
Psychiatric disorders
Insomnia
|
7.7%
3/39
|
|
Reproductive system and breast disorders
Irregular menses (change from baseline)
|
2.6%
1/39
|
|
Investigations
Leukocytes (total WBC)
|
12.8%
5/39
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
2.6%
1/39
|
|
Psychiatric disorders
Mood alteration, Anxiety
|
5.1%
2/39
|
|
Psychiatric disorders
Mood alteration, Depression
|
10.3%
4/39
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Oral cavity
|
46.2%
18/39
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
10.3%
4/39
|
|
Gastrointestinal disorders
Nausea
|
48.7%
19/39
|
|
Nervous system disorders
Neurology - Other
|
25.6%
10/39
|
|
Nervous system disorders
Neuropathy: motor
|
2.6%
1/39
|
|
Nervous system disorders
Neuropathy: sensory
|
30.8%
12/39
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
7.7%
3/39
|
|
Eye disorders
Ocular/Visual - Other
|
2.6%
1/39
|
|
Gastrointestinal disorders
Pain, Abdomen NOS
|
25.6%
10/39
|
|
Gastrointestinal disorders
Pain, Anus
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Back
|
17.9%
7/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Bone
|
2.6%
1/39
|
|
General disorders
Pain, Chest/thorax NOS
|
5.1%
2/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Extremity-limb
|
5.1%
2/39
|
|
Nervous system disorders
Pain, Head/headache
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Joint
|
2.6%
1/39
|
|
Gastrointestinal disorders
Pain, Rectum
|
2.6%
1/39
|
|
Gastrointestinal disorders
Pain, Stomach
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.6%
1/39
|
|
Investigations
Platelets
|
7.7%
3/39
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
7.7%
3/39
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
43.6%
17/39
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
2.6%
1/39
|
|
General disorders
Rigors/chills
|
2.6%
1/39
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
7.7%
3/39
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
7.7%
3/39
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
7.7%
3/39
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.6%
1/39
|
|
Nervous system disorders
Tremor
|
2.6%
1/39
|
|
General disorders
Ulceration
|
2.6%
1/39
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
5.1%
2/39
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
2.6%
1/39
|
|
Injury, poisoning and procedural complications
Vessel injury-vein, Other NOS
|
2.6%
1/39
|
|
Eye disorders
Vision-blurred vision
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
5.1%
2/39
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
9/39
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
17.9%
7/39
|
|
Investigations
Weight loss
|
17.9%
7/39
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place