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Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus

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ClinicalTrials.gov Identifier: NCT00476086
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : April 13, 2016
Last Update Posted : August 24, 2018
Sponsor:
Collaborators:
Sanofi
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Susana M. Campos, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mixed Mullerian Tumors of the Uterus
Interventions Drug: Gemcitabine
Drug: Oxaliplatin
Radiation: Radiation
Enrollment 20
Recruitment Details 20 participants were enrolled between May 2007 and August 2011.
Pre-assignment Details  
Arm/Group Title Oxaliplatin/ Gemcitabine Then Radiation
Hide Arm/Group Description Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
Period Title: Overall Study
Started 20
Received Chemotherapy 19
Received Radiation 15
Completed 15
Not Completed 5
Reason Not Completed
Alternative therapy             1
Progressive Disease             4
Arm/Group Title Oxaliplatin/ Gemcitabine Then Radiation
Hide Arm/Group Description

Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.

on

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
The baseline population is comprised of all enrolled patients.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
63
(49 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
20
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Chemotherapy Completion Rate
Hide Description Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.
Time Frame 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all participants who started chemotherapy.
Arm/Group Title Oxaliplatin/ Gemcitabine Then Radiation
Hide Arm/Group Description:
Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
100
(85 to 100)
2.Secondary Outcome
Title Radiation Therapy Completion Rate
Hide Description Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease
Time Frame Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of all participants who started chemotherapy.
Arm/Group Title Oxaliplatin/ Gemcitabine Then Radiation
Hide Arm/Group Description:
Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
79
(58 to 92)
Time Frame Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy.
Adverse Event Reporting Description Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
 
Arm/Group Title Oxaliplatin/ Gemcitabine Radiation
Hide Arm/Group Description Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
All-Cause Mortality
Oxaliplatin/ Gemcitabine Radiation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oxaliplatin/ Gemcitabine Radiation
Affected / at Risk (%) Affected / at Risk (%)
Total   2/19 (10.53%)   2/15 (13.33%) 
Infections and infestations     
Infection Gr0-2 neut, colon  1  1/19 (5.26%)  0/15 (0.00%) 
Investigations     
ALT, SGPT  1  1/19 (5.26%)  0/15 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  0/19 (0.00%)  1/15 (6.67%) 
Hyperglycemia  1  0/19 (0.00%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxaliplatin/ Gemcitabine Radiation
Affected / at Risk (%) Affected / at Risk (%)
Total   15/19 (78.95%)   14/15 (93.33%) 
Blood and lymphatic system disorders     
Hemoglobin  1  1/19 (5.26%)  0/15 (0.00%) 
Gastrointestinal disorders     
Abdomen, pain  1  0/19 (0.00%)  3/15 (20.00%) 
Constipation  1  8/19 (42.11%)  3/15 (20.00%) 
Diarrhea w/o prior colostomy  1  2/19 (10.53%)  11/15 (73.33%) 
Dry mouth  1  1/19 (5.26%)  0/15 (0.00%) 
Dyspepsia  1  3/19 (15.79%)  0/15 (0.00%) 
Dysphagia  1  1/19 (5.26%)  0/15 (0.00%) 
GI-other  1  2/19 (10.53%)  1/15 (6.67%) 
Hemorrhoids  1  0/19 (0.00%)  3/15 (20.00%) 
Nausea  1  10/19 (52.63%)  6/15 (40.00%) 
Rectum, pain  1  0/19 (0.00%)  1/15 (6.67%) 
Vomiting  1  4/19 (21.05%)  1/15 (6.67%) 
General disorders     
Constitutional, other  1  2/19 (10.53%)  0/15 (0.00%) 
Edema limb  1  0/19 (0.00%)  1/15 (6.67%) 
Fatigue  1  14/19 (73.68%)  9/15 (60.00%) 
Fever w/o neutropenia  1  1/19 (5.26%)  0/15 (0.00%) 
Injection site reaction  1  3/19 (15.79%)  0/15 (0.00%) 
Pain NOS  1  1/19 (5.26%)  0/15 (0.00%) 
Pain-other  1  1/19 (5.26%)  1/15 (6.67%) 
Rigors/chills  1  1/19 (5.26%)  0/15 (0.00%) 
Immune system disorders     
Allergic reaction  1  0/19 (0.00%)  1/15 (6.67%) 
Infections and infestations     
Infection w/ gr3-4 neut, anal/perianal  1  1/19 (5.26%)  0/15 (0.00%) 
Infection-other  1  0/19 (0.00%)  1/15 (6.67%) 
Injury, poisoning and procedural complications     
Radiation dermatitis  1  0/19 (0.00%)  5/15 (33.33%) 
Investigations     
ALT, SGPT  1  1/19 (5.26%)  0/15 (0.00%) 
AST, SGOT  1  1/19 (5.26%)  0/15 (0.00%) 
Leukocytes  1  2/19 (10.53%)  1/15 (6.67%) 
Neutrophils  1  0/19 (0.00%)  2/15 (13.33%) 
Platelets  1  2/19 (10.53%)  0/15 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  1/19 (5.26%)  2/15 (13.33%) 
Dehydration  1  0/19 (0.00%)  1/15 (6.67%) 
Hypokalemia  1  1/19 (5.26%)  0/15 (0.00%) 
Hypomagnesemia  1  1/19 (5.26%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back, pain  1  1/19 (5.26%)  0/15 (0.00%) 
Extremity-limb, pain  1  1/19 (5.26%)  0/15 (0.00%) 
Joint, pain  1  0/19 (0.00%)  1/15 (6.67%) 
Muscle, pain  1  3/19 (15.79%)  0/15 (0.00%) 
Musculoskeletal/soft tissue-other  1  1/19 (5.26%)  0/15 (0.00%) 
Nervous system disorders     
Dizziness  1  1/19 (5.26%)  0/15 (0.00%) 
Head/headache  1  1/19 (5.26%)  0/15 (0.00%) 
Neurologic-other  1  12/19 (63.16%)  5/15 (33.33%) 
Neuropathy-sensory  1  9/19 (47.37%)  1/15 (6.67%) 
Taste disturbance  1  2/19 (10.53%)  0/15 (0.00%) 
Psychiatric disorders     
Anxiety  1  1/19 (5.26%)  0/15 (0.00%) 
Depression  1  1/19 (5.26%)  0/15 (0.00%) 
Renal and urinary disorders     
Urinary frequency/urgency  1  0/19 (0.00%)  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/19 (5.26%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  2/19 (10.53%)  0/15 (0.00%) 
Dry skin  1  0/19 (0.00%)  1/15 (6.67%) 
Hyperpigmentation  1  0/19 (0.00%)  1/15 (6.67%) 
Pruritus/itching  1  1/19 (5.26%)  0/15 (0.00%) 
Rash/desquamation  1  1/19 (5.26%)  2/15 (13.33%) 
Rash: acne/acneiform  1  2/19 (10.53%)  0/15 (0.00%) 
Skin, pain  1  1/19 (5.26%)  2/15 (13.33%) 
Skin-other  1  2/19 (10.53%)  0/15 (0.00%) 
Vascular disorders     
Flushing  1  1/19 (5.26%)  1/15 (6.67%) 
Hot flashes  1  1/19 (5.26%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Susana M. Campos, MD, MPH
Organization: Dana-Farber Cancer Institute
Phone: 617-632-5269
Responsible Party: Susana M. Campos, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00476086     History of Changes
Other Study ID Numbers: 06-063
First Submitted: May 17, 2007
First Posted: May 21, 2007
Results First Submitted: March 10, 2016
Results First Posted: April 13, 2016
Last Update Posted: August 24, 2018