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Trial record 1 of 2 for:    "Esophagus Adenocarcinoma" | "Dexamethasone"
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A Study of Docetaxel in Combination With Capecitabine in Stomach and Esophagus Cancers

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ClinicalTrials.gov Identifier: NCT00177255
Recruitment Status : Terminated (Roche has withdrawn support)
First Posted : September 15, 2005
Results First Posted : February 8, 2016
Last Update Posted : February 8, 2016
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Roche Pharma AG
Information provided by (Responsible Party):
Nathan Bahary, MD, University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer
Interventions Drug: Docetaxel
Drug: Capecitabine
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Docetaxel + Capecitabine
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 39
Completed 39
Not Completed 0
Arm/Group Title Docetaxel + Capecitabine
Hide Arm/Group Description

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 Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 39 participants
61
(21 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
7
  17.9%
Male
32
  82.1%
1.Primary Outcome
Title Overall Survival
Hide Description The time interval between the date on which a patient first received protocol treatment and the documented date of death.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Docetaxel + Capecitabine
Hide Arm/Group Description:

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 Number of Participants Analyzed 39
Median (95% Confidence Interval)
Unit of Measure: Months
10.7
(6.8 to 12.1)
2.Secondary Outcome
Title Overall Response Rate
Hide Description The number of responders (complete responders + partial responders) divided by the number of evaluable patients.
Time Frame Every 2 cycles (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Docetaxel + Capecitabine
Hide Arm/Group Description:

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 Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.2
(15 to 44.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Docetaxel + Capecitabine
Hide Arm/Group Description

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.

All-Cause Mortality
Docetaxel + Capecitabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Docetaxel + Capecitabine
Affected / at Risk (%)
Total   20/39 (51.28%) 
Blood and lymphatic system disorders   
Blood/Bone Marrow-Other  1/39 (2.56%) 
Febrile neutropenia  1/39 (2.56%) 
Cardiac disorders   
Ventricular arrhythmia  1/39 (2.56%) 
Cardiovascular/General-Other  2/39 (5.13%) 
Eye disorders   
Ocular/Visual-Other  1/39 (2.56%) 
Gastrointestinal disorders   
Nausea  1/39 (2.56%) 
Gastrointestinal-Other  4/39 (10.26%) 
Colitis  1/39 (2.56%) 
Diarrhea  1/39 (2.56%) 
General disorders   
Constitutional Symptoms-Other  6/39 (15.38%) 
Infections and infestations   
Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)  1/39 (2.56%) 
Investigations   
Neutrophils/granulocytes (ANC/AGC)  1/39 (2.56%) 
Metabolism and nutrition disorders   
Anorexia  1/39 (2.56%) 
Dehydration  1/39 (2.56%) 
Hypoglycemia  1/39 (2.56%) 
Calcium, serum-low (hypocalcemia)  1/39 (2.56%) 
Phosphate, serum-low (hypophosphatemia)  1/39 (2.56%) 
Nervous system disorders   
Dizziness  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary-Other  4/39 (10.26%) 
Dyspnea (shortness of breath)  1/39 (2.56%) 
Vascular disorders   
Hypotension  1/39 (2.56%) 
Thrombosis/Embolism  1/39 (2.56%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Docetaxel + Capecitabine
Affected / at Risk (%)
Total   37/39 (94.87%) 
Blood and lymphatic system disorders   
Hemoglobin  14/39 (35.90%) 
Hemorrhage/Bleeding - Other  3/39 (7.69%) 
Eye disorders   
Dry eye syndrome  1/39 (2.56%) 
Ocular/Visual - Other  1/39 (2.56%) 
Vision-blurred vision  1/39 (2.56%) 
Watery eye (epiphora, tearing)  7/39 (17.95%) 
Gastrointestinal disorders   
Constipation  10/39 (25.64%) 
Diarrhea  16/39 (41.03%) 
Dry mouth/salivary gland (xerostomia)  1/39 (2.56%) 
Dysphagia (difficulty swallowing)  5/39 (12.82%) 
Flatulence  3/39 (7.69%) 
Gastrointestinal - Other  3/39 (7.69%) 
Heartburn/dyspepsia  5/39 (12.82%) 
Hemorrhage, GI, Lower GI NOS  1/39 (2.56%) 
Hemorrhage, GI, Rectum  2/39 (5.13%) 
Hemorrhoids  1/39 (2.56%) 
Mucositis/stomatitis (clinical exam), Oral cavity  18/39 (46.15%) 
Nausea  19/39 (48.72%) 
Pain, Abdomen NOS  10/39 (25.64%) 
Pain, Anus  1/39 (2.56%) 
Pain, Rectum  1/39 (2.56%) 
Pain, Stomach  1/39 (2.56%) 
Salivary gland changes/saliva  3/39 (7.69%) 
Taste alteration (dysgeusia)  3/39 (7.69%) 
Vomiting  9/39 (23.08%) 
General disorders   
Constitutional Symptoms - Other  2/39 (5.13%) 
Edema: head and neck  2/39 (5.13%) 
Edema: limb  9/39 (23.08%) 
Edema: trunk/genital  2/39 (5.13%) 
Fatigue (asthenia, lethargy, malaise)  26/39 (66.67%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  3/39 (7.69%) 
Injection site reaction/extravasation changes  1/39 (2.56%) 
Pain, Chest/thorax NOS  2/39 (5.13%) 
Rigors/chills  1/39 (2.56%) 
Ulceration  1/39 (2.56%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1/39 (2.56%) 
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  2/39 (5.13%) 
Infections and infestations   
Infection with normal ANC or Grade 1 or 2 neutrophils, Sinus  1/39 (2.56%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS  1/39 (2.56%) 
Injury, poisoning and procedural complications   
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1/39 (2.56%) 
Fracture  1/39 (2.56%) 
Vessel injury-vein, Other NOS  1/39 (2.56%) 
Investigations   
Leukocytes (total WBC)  5/39 (12.82%) 
Neutrophils/granulocytes (ANC/AGC)  3/39 (7.69%) 
Platelets  3/39 (7.69%) 
Weight loss  7/39 (17.95%) 
Metabolism and nutrition disorders   
Anorexia  14/39 (35.90%) 
Dehydration  5/39 (12.82%) 
Glucose, serum-high (hyperglycemia)  4/39 (10.26%) 
Metabolic/Laboratory - Other  1/39 (2.56%) 
Potassium, serum-high (hyperkalemia)  1/39 (2.56%) 
Musculoskeletal and connective tissue disorders   
Pain, Back  7/39 (17.95%) 
Pain, Bone  1/39 (2.56%) 
Pain, Extremity-limb  2/39 (5.13%) 
Pain, Joint  1/39 (2.56%) 
Nervous system disorders   
Dizziness  4/39 (10.26%) 
Neurology - Other  10/39 (25.64%) 
Neuropathy: motor  1/39 (2.56%) 
Neuropathy: sensory  12/39 (30.77%) 
Pain, Head/headache  1/39 (2.56%) 
Somnolence/depressed level of consciousness  1/39 (2.56%) 
Tremor  1/39 (2.56%) 
Psychiatric disorders   
Insomnia  3/39 (7.69%) 
Mood alteration, Anxiety  2/39 (5.13%) 
Mood alteration, Depression  4/39 (10.26%) 
Renal and urinary disorders   
Renal/Genitourinary - Other  1/39 (2.56%) 
Urinary frequency/urgency  2/39 (5.13%) 
Urinary retention (including neurogenic bladder)  1/39 (2.56%) 
Reproductive system and breast disorders   
Irregular menses (change from baseline)  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders   
Cough  5/39 (12.82%) 
Dyspnea (shortness of breath)  9/39 (23.08%) 
Hiccoughs (hiccups, singultus)  2/39 (5.13%) 
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)  2/39 (5.13%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other  5/39 (12.82%) 
Dry skin  2/39 (5.13%) 
Hair loss/alopecia (scalp or body)  6/39 (15.38%) 
Hyperpigmentation  1/39 (2.56%) 
Nail changes  4/39 (10.26%) 
Photosensitivity  1/39 (2.56%) 
Rash/desquamation  3/39 (7.69%) 
Rash: hand-foot skin reaction  17/39 (43.59%) 
Sweating (diaphoresis)  3/39 (7.69%) 
Vascular disorders   
Flushing  4/39 (10.26%) 
Hypotension  2/39 (5.13%) 
Thrombosis/thrombus/embolism  1/39 (2.56%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nathan Bahary, MD
Organization: University of Pittsburgh
Phone: 412-864-7764
EMail: baharyn@upmc.edu
Layout table for additonal information
Responsible Party: Nathan Bahary, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177255     History of Changes
Other Study ID Numbers: 04-026
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: January 10, 2016
Results First Posted: February 8, 2016
Last Update Posted: February 8, 2016