Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 95 of 2006 for:    oxaliplatin

Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354887
Recruitment Status : Completed
First Posted : July 20, 2006
Results First Posted : July 14, 2011
Last Update Posted : October 29, 2012
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastrointestinal Cancer
Interventions Drug: Capecitabine
Drug: Oxaliplatin
Enrollment 31
Recruitment Details Recruitment Period: November 1, 2004 and July 31, 2007. All participants recruited at UT MD Anderson Cancer Center.
Pre-assignment Details Thirty-one patients were enrolled onto the study, and 30 patients received study treatment. One patient did not meet eligibility criteria and did not receive any study treatment. One additional patient was removed from the study after one treatment cycle.
Arm/Group Title Oxaliplatin + Capecitabine
Hide Arm/Group Description Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
Period Title: Overall Study
Started 30
Completed 29
Not Completed 1
Arm/Group Title Oxaliplatin + Capecitabine
Hide Arm/Group Description Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
62
(41 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
12
  40.0%
Male
18
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Number of Participants With Overall Response
Hide Description Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR.
Time Frame Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent-to-treat; One patient developed an acute flare of Crohn’s disease after one cycle of study treatment and was removed from study without undergoing restaging scans.
Arm/Group Title Oxaliplatin + Capecitabine
Hide Arm/Group Description:
Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
Participants with CR 3
Participants with PR 12
Time Frame Adverse event data were collected from November 18, 2004 to July 26, 2007 or a total of three (3) years and five (5) months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxaliplatin + Capecitabine
Hide Arm/Group Description Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
All-Cause Mortality
Oxaliplatin + Capecitabine
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Oxaliplatin + Capecitabine
Affected / at Risk (%)
Total   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oxaliplatin + Capecitabine
Affected / at Risk (%)
Total   30/30 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  8/30 (26.67%) 
Neutophils/granulocytes(ANC/AGC)  1  12/30 (40.00%) 
Cardiac disorders   
Chest Pain  1  2/30 (6.67%) 
Eye disorders   
Dry Eyes  1  2/30 (6.67%) 
Watery Eyes  1  6/30 (20.00%) 
Gastrointestinal disorders   
Abdominal Pain  1  12/30 (40.00%) 
Abdominal bloating  1  3/30 (10.00%) 
Anorexia  1  17/30 (56.67%) 
Belching  1  2/30 (6.67%) 
Constipation  1  16/30 (53.33%) 
Diarrhea  1  19/30 (63.33%) 
Hemorrhage (abdominal wound)  1  2/30 (6.67%) 
Nausea  2  25/30 (83.33%) 
Vomiting  1  19/30 (63.33%) 
Weight Loss  1  8/30 (26.67%) 
General disorders   
Cold Intolerance  1  2/30 (6.67%) 
Dehydration  1  3/30 (10.00%) 
Dizziness  1  6/30 (20.00%) 
Dry mouth  1  4/30 (13.33%) 
Dysphagia  1  4/30 (13.33%) 
Fatigue  1  22/30 (73.33%) 
Fever without neutropenia  1  9/30 (30.00%) 
Headache  1  11/30 (36.67%) 
Heartburn  1  2/30 (6.67%) 
Insomnia  1  2/30 (6.67%) 
Mood alteration(depression)  1  11/30 (36.67%) 
Mucositis (Oral Cavity)  1  6/30 (20.00%) 
Neuropathy-Sensory  1  28/30 (93.33%) 
Pain (Muscle)  1  14/30 (46.67%) 
Pain(throat/larynx)  1  2/30 (6.67%) 
Rigors (Chills)  1  8/30 (26.67%) 
Taste Alteration  1  9/30 (30.00%) 
Infections and infestations   
Infection without neutropenia  1  3/30 (10.00%) 
Metabolism and nutrition disorders   
Alkaline Phosphatase  1  9/30 (30.00%) 
Bilirubin  1  4/30 (13.33%) 
Creatinine  1  2/30 (6.67%) 
Decreased Total Protein, Serum  1  2/30 (6.67%) 
Elevated phosphorus  1  2/30 (6.67%) 
Hyperglycemia  1  8/30 (26.67%) 
Hypoalbuminemia  1  7/30 (23.33%) 
Hypoatremia  1  5/30 (16.67%) 
Hypocalcemia  1  4/30 (13.33%) 
Hypokalemia  1  9/30 (30.00%) 
Hypomagnesemia  1  15/30 (50.00%) 
Hypophosphatemia  1  3/30 (10.00%) 
Platelets decreased  1  11/30 (36.67%) 
Serum Glutamic Oxaloacetic Transaminase (AST,SGOT)  1  22/30 (73.33%) 
Serum Glutamic Pyruvic Transaminase (ALT,SGPT)  1  12/30 (40.00%) 
Total elevated protein  1  4/30 (13.33%) 
Musculoskeletal and connective tissue disorders   
Pain(joint)  1  12/30 (40.00%) 
Renal and urinary disorders   
Urinary Tract Infection  1  3/30 (10.00%) 
Reproductive system and breast disorders   
Irregular Menses  1  2/30 (6.67%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/30 (6.67%) 
Dyspnea  1  7/30 (23.33%) 
Hiccoughs  1  2/30 (6.67%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  6/30 (20.00%) 
Dry Skin  1  5/30 (16.67%) 
Hand-foot syndrome  1  6/30 (20.00%) 
Hyperpigmentation  1  2/30 (6.67%) 
Pruritus  1  5/30 (16.67%) 
Rash desquamation  1  9/30 (30.00%) 
Rash(hand/foot skin reaction)  1  4/30 (13.33%) 
Vascular disorders   
Edema (limb)  1  6/30 (20.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, CTCAE V3.0
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: Robert Wolff, MD / Professor
Organization: UT MD Anderson Cancer Center
Phone: 713-792-2828
EMail: mjlim@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00354887    
Other Study ID Numbers: 2003-0827
First Submitted: July 18, 2006
First Posted: July 20, 2006
Results First Submitted: June 14, 2011
Results First Posted: July 14, 2011
Last Update Posted: October 29, 2012