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Trial record 98 of 1973 for:    oxaliplatin

Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT00338988
Recruitment Status : Completed
First Posted : June 20, 2006
Results First Posted : December 8, 2010
Last Update Posted : August 1, 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
Conditions Cancer of the Gallbladder
Cancer of the Biliary Tract
Interventions Drug: Capecitabine
Drug: Oxaliplatin
Enrollment 44
Recruitment Details The recruitment period: August 28, 2003 to July 31, 2006. All participants were recruited at UT MD Anderson Cancer Center.
Pre-assignment Details Following enrollment, one of the forty-four participants was found to be ineligible and never assigned to a group.
Arm/Group Title Capecitabine + Oxaliplatin
Hide Arm/Group Description Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
Period Title: Overall Study
Started 44
Completed 43
Not Completed 1
Arm/Group Title Capecitabine + Oxaliplatin
Hide Arm/Group Description Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants
68
(28 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
27
  61.4%
Male
17
  38.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants
44
1.Primary Outcome
Title Number of Participants With Objective Response
Hide Description Objective Response = Complete Response + Partial Response. Response evaluated using modification of new international criteria proposed by RECIST [changes in only largest diameter (unidimensional measurement) of tumor lesions used in the RECIST criteria]. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time Frame Baseline with restaging every 3 cycles (cycle=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol. One participant was found ineligible and received no treatment.
Arm/Group Title Capecitabine + Oxaliplatin
Hide Arm/Group Description:
Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
1
Time Frame A total 3 years from August 2003 to December 2006.
Adverse Event Reporting Description The subjects were provided a study calendar every cycle and instructed to record all side effects experienced.
 
Arm/Group Title Stratum: 1 Prior Regimen Stratum 2: No Prior Therapy
Hide Arm/Group Description Received prior therapy. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Day 1-14. Previously untreated. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Day 1-14.
All-Cause Mortality
Stratum: 1 Prior Regimen Stratum 2: No Prior Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stratum: 1 Prior Regimen Stratum 2: No Prior Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/18 (22.22%)      2/26 (7.69%)    
Cardiac disorders     
Congestive Heart Failure  1  0/18 (0.00%)  0 1/26 (3.85%)  1
Gastrointestinal disorders     
Abdominal Pain  1  0/18 (0.00%)  0 1/26 (3.85%)  1
Dehydration  1  1/18 (5.56%)  1 0/26 (0.00%)  0
Diarrhea  1  1/18 (5.56%)  1 0/26 (0.00%)  0
Vomiting  1  1/18 (5.56%)  1 0/26 (0.00%)  0
Immune system disorders     
Allergic Reaction  1 [1]  1/18 (5.56%)  1 0/26 (0.00%)  0
Nervous system disorders     
Seizure  1  0/18 (0.00%)  0 1/26 (3.85%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
[1]
Allergy/Immunology
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stratum: 1 Prior Regimen Stratum 2: No Prior Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/18 (100.00%)      26/26 (100.00%)    
Blood and lymphatic system disorders     
Anemia  2  2/18 (11.11%)  4/26 (15.38%) 
Leukopenia  1  0/18 (0.00%)  7/26 (26.92%) 
Thrombocytopenia  1  1/18 (5.56%)  9/26 (34.62%) 
Gastrointestinal disorders     
Abdominal Pain  1  5/18 (27.78%)  11/26 (42.31%) 
Anorexia  1  4/18 (22.22%)  14/26 (53.85%) 
Diarrhea  1  8/18 (44.44%)  14/26 (53.85%) 
Flatulence  1  2/18 (11.11%)  6/26 (23.08%) 
Nausea  1  11/18 (61.11%)  23/26 (88.46%) 
Stomatitis  1  1/18 (5.56%)  4/26 (15.38%) 
Taste Disturbance  1  2/18 (11.11%)  8/26 (30.77%) 
Vomiting  1  4/18 (22.22%)  16/26 (61.54%) 
General disorders     
Fatigue  1  9/18 (50.00%)  18/26 (69.23%) 
Headache  2  4/18 (22.22%)  4/26 (15.38%) 
Hepatobiliary disorders     
Alkaline Phosphatase (increase)  1  2/18 (11.11%)  5/26 (19.23%) 
Serum Glutamic Oxaloacetic Transaminase (AST, SGOT)  1  3/18 (16.67%)  5/26 (19.23%) 
Musculoskeletal and connective tissue disorders     
Jaw cramps  1  1/18 (5.56%)  4/26 (15.38%) 
Myalgia  1  0/18 (0.00%)  9/26 (34.62%) 
Nervous system disorders     
Dizziness  1  0/18 (0.00%)  6/26 (23.08%) 
Neuropathy-sensory  1  15/18 (83.33%)  24/26 (92.31%) 
Skin and subcutaneous tissue disorders     
Hand-foot skin reaction  1  4/18 (22.22%)  8/26 (30.77%) 
Hyperpigmentation  1  0/18 (0.00%)  4/26 (15.38%) 
Pruritus  1  2/18 (11.11%)  4/26 (15.38%) 
Rash (Erythema multiform, Desquamation...)  1  2/18 (11.11%)  1/26 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
2
Term from vocabulary, CTCAE 2
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: Melanie Thomas, MD/Assistant Professor
Organization: University Texas MD Anderson Cancer Center
Phone: 713-794-4869
EMail: mjlim@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00338988     History of Changes
Other Study ID Numbers: 2003-0340
First Submitted: June 16, 2006
First Posted: June 20, 2006
Results First Submitted: November 3, 2010
Results First Posted: December 8, 2010
Last Update Posted: August 1, 2012