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Pemetrexed Plus Gemcitabine or Carboplatin for Patients With Advanced Malignant Pleural Mesothelioma

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ClinicalTrials.gov Identifier: NCT00101283
Recruitment Status : Completed
First Posted : January 10, 2005
Results First Posted : March 4, 2010
Last Update Posted : December 4, 2012
Sponsor:
Collaborators:
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mesothelioma
Interventions Drug: pemetrexed disodium
Drug: gemcitabine hydrochloride
Drug: carboplatin
Enrollment 32
Recruitment Details The study was activated on November 1, 2005, suspended to accrual on July 12, 2007 for response evaluation, and closed to accrual on April 1, 2008.
Pre-assignment Details  
Arm/Group Title Pemetrexed/Carboplatin Pemetrexed/Gemcitabine
Hide Arm/Group Description Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle. Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
Period Title: Overall Study
Started 16 16
Began Treatment 16 13
Completed 16 13
Not Completed 0 3
Reason Not Completed
Withdrawal by Subject             0             1
Insurance Refusal             0             1
Prostate Cancer Recurrence             0             1
Arm/Group Title Pemetrexed/Carboplatin Pemetrexed/Gemcitabine Total
Hide Arm/Group Description Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle. Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle. Total of all reporting groups
Overall Number of Baseline Participants 16 13 29
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 13 participants 29 participants
72
(55 to 78)
68
(53 to 80)
71
(53 to 80)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
Female
2
  12.5%
12
  92.3%
14
  48.3%
Male
14
  87.5%
1
   7.7%
15
  51.7%
[1]
Measure Description: Gender of participants who began treatment.
1.Primary Outcome
Title Best Overall Response by RECIST Criteria (Version 1.0)
Hide Description Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression.
Time Frame Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.
Arm/Group Title Pemetrexed/Carboplatin Pemetrexed/Gemcitabine
Hide Arm/Group Description:
Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
Overall Number of Participants Analyzed 16 13
Measure Type: Number
Unit of Measure: eligible, treated participants
Partial Response 3 0
Stable Disease 7 6
Progression 5 5
Unevaluable 1 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed/Carboplatin
Comments The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Overall Response Percent
Estimated Value 18.8
Confidence Interval (2-Sided) 90%
5.4 to 41.7
Estimation Comments Overall response percent for Pemetrexed/Carboplatin arm (percent of eligible, treated patients with complete or partial response)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pemetrexed/Gemcitabine
Comments The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Overall Response Percent
Estimated Value 0.0
Confidence Interval (2-Sided) 90%
0.0 to 20.6
Estimation Comments Overall response percent for Pemetrexed/Gemcitabine arm (percent of eligible, treated patients with complete or partial response)
2.Secondary Outcome
Title Overall Survival
Hide Description Time from randomization to death. Patients alive at last follow-up were censored.
Time Frame Assessed every 3 months for 2 years, then every 6 months for 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.
Arm/Group Title Pemetrexed/Carboplatin Pemetrexed/Gemcitabine
Hide Arm/Group Description:
Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
Overall Number of Participants Analyzed 16 13
Median (95% Confidence Interval)
Unit of Measure: Months
13.0
(5.6 to 21.9)
6.0
(3.9 to 14.0)
3.Secondary Outcome
Title Progression-Free Survival
Hide Description Time from randomization to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.
Time Frame Assessed every 3 months for 2 years, then every 6 months for 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.
Arm/Group Title Pemetrexed/Carboplatin Pemetrexed/Gemcitabine
Hide Arm/Group Description:
Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
Overall Number of Participants Analyzed 16 13
Median (95% Confidence Interval)
Unit of Measure: Months
4.1
(1.7 to 6.6)
3.3
(1.6 to 5.2)
Time Frame Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pemetrexed/Carboplatin Pemetrexed/Gemcitabine
Hide Arm/Group Description Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle. Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
All-Cause Mortality
Pemetrexed/Carboplatin Pemetrexed/Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pemetrexed/Carboplatin Pemetrexed/Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   10/16 (62.50%)   13/13 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  3/16 (18.75%)  2/13 (15.38%) 
Leukopenia  1  1/16 (6.25%)  10/13 (76.92%) 
Lymphopenia  1  1/16 (6.25%)  0/13 (0.00%) 
Neutropenia  1  3/16 (18.75%)  12/13 (92.31%) 
Thrombocytopenia  1  2/16 (12.50%)  2/13 (15.38%) 
Gastrointestinal disorders     
Anorexia  1  0/16 (0.00%)  1/13 (7.69%) 
Nausea  1  1/16 (6.25%)  1/13 (7.69%) 
General disorders     
Fatigue  1  2/16 (12.50%)  3/13 (23.08%) 
Investigations     
Elevated bilirubin  1  1/16 (6.25%)  0/13 (0.00%) 
Nervous system disorders     
Arachnoiditis/meningismus/radiculitis  1  0/16 (0.00%)  1/13 (7.69%) 
Dizziness  1  1/16 (6.25%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chest/thoracic pain  1  1/16 (6.25%)  1/13 (7.69%) 
Dyspnea  1  2/16 (12.50%)  1/13 (7.69%) 
Hypoxia  1  1/16 (6.25%)  0/13 (0.00%) 
Pneumonitis/pulmonary infiltrates  1  1/16 (6.25%)  0/13 (0.00%) 
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 5%
Pemetrexed/Carboplatin Pemetrexed/Gemcitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   16/16 (100.00%)   13/13 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  14/16 (87.50%)  12/13 (92.31%) 
Hemolysis  1  0/16 (0.00%)  1/13 (7.69%) 
Leukopenia  1  13/16 (81.25%)  11/13 (84.62%) 
Lymphopenia  1  2/16 (12.50%)  1/13 (7.69%) 
Neutropenia  1  11/16 (68.75%)  8/13 (61.54%) 
Thrombocytopenia  1  9/16 (56.25%)  7/13 (53.85%) 
Edema, limb  1  0/16 (0.00%)  3/13 (23.08%) 
Ear and labyrinth disorders     
Hearing loss (without baseline audiogram, not in monitoring program)  1  1/16 (6.25%)  0/13 (0.00%) 
Endocrine disorders     
Hot flashes  1  1/16 (6.25%)  0/13 (0.00%) 
Eye disorders     
Tearing  1  1/16 (6.25%)  0/13 (0.00%) 
Ocular - other  1  1/16 (6.25%)  0/13 (0.00%) 
Gastrointestinal disorders     
Anorexia  1  5/16 (31.25%)  9/13 (69.23%) 
Constipation  1  6/16 (37.50%)  5/13 (38.46%) 
Dehydration  1  0/16 (0.00%)  2/13 (15.38%) 
Diarrhea w/o prior colostomy  1  3/16 (18.75%)  2/13 (15.38%) 
Distention/bloating, abdominal  1  0/16 (0.00%)  2/13 (15.38%) 
Dry mouth  1  1/16 (6.25%)  0/13 (0.00%) 
Muco/stomatitis (symptom), oral cavity  1  0/16 (0.00%)  1/13 (7.69%) 
Muco/stomatitis (symptom), pharynx  1  5/16 (31.25%)  2/13 (15.38%) 
Nausea  1  9/16 (56.25%)  4/13 (30.77%) 
Taste disturbance  1  3/16 (18.75%)  3/13 (23.08%) 
Vomiting  1  3/16 (18.75%)  4/13 (30.77%) 
GI - other  1  0/16 (0.00%)  1/13 (7.69%) 
Colitis, infectious  1  1/16 (6.25%)  0/13 (0.00%) 
Abdomen, pain  1  1/16 (6.25%)  0/13 (0.00%) 
General disorders     
Fatigue  1  15/16 (93.75%)  12/13 (92.31%) 
Fever w/o neutropenia  1  3/16 (18.75%)  3/13 (23.08%) 
Insomnia  1  1/16 (6.25%)  3/13 (23.08%) 
Rigors/chills  1  2/16 (12.50%)  1/13 (7.69%) 
Sweating  1  1/16 (6.25%)  1/13 (7.69%) 
Weight gain  1  1/16 (6.25%)  1/13 (7.69%) 
Weight loss  1  3/16 (18.75%)  5/13 (38.46%) 
Hepatobiliary disorders     
Liver, pain  1  0/16 (0.00%)  1/13 (7.69%) 
Immune system disorders     
Allergic rhinitis  1  1/16 (6.25%)  0/13 (0.00%) 
Infections and infestations     
Infection w/ gr 0-2 neutrophils, sinus  1  2/16 (12.50%)  0/13 (0.00%) 
Investigations     
Elevated ALT, SGPT (serum glutamic pyruvic transaminase)  1  5/16 (31.25%)  6/13 (46.15%) 
Elevated AST, SGOT (serum glutamic oxaloacetic transaminase)  1  3/16 (18.75%)  6/13 (46.15%) 
Elevated creatinine  1  1/16 (6.25%)  2/13 (15.38%) 
Metabolism and nutrition disorders     
Hypoalbuminemia  1  3/16 (18.75%)  11/13 (84.62%) 
Elevated alkaline phosphatase  1  3/16 (18.75%)  9/13 (69.23%) 
Elevated bilirubin  1  1/16 (6.25%)  2/13 (15.38%) 
Hyperglycemia  1  4/16 (25.00%)  2/13 (15.38%) 
Hemoglobinuria  1  0/16 (0.00%)  1/13 (7.69%) 
Hyponatremia  1  1/16 (6.25%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/16 (0.00%)  1/13 (7.69%) 
Musculoskeletal/soft tissue - other  1  0/16 (0.00%)  1/13 (7.69%) 
Bone, pain  1  1/16 (6.25%)  0/13 (0.00%) 
Extremity - limb, pain  1  0/16 (0.00%)  1/13 (7.69%) 
Joint, pain  1  0/16 (0.00%)  1/13 (7.69%) 
Muscle, pain  1  2/16 (12.50%)  2/13 (15.38%) 
Nervous system disorders     
Dizziness  1  1/16 (6.25%)  2/13 (15.38%) 
Depression  1  0/16 (0.00%)  1/13 (7.69%) 
Neuropathy, sensory  1  1/16 (6.25%)  1/13 (7.69%) 
Renal and urinary disorders     
Urinary frequency/urgency  1  0/16 (0.00%)  1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders     
Chest/thoracic pain  1  1/16 (6.25%)  0/13 (0.00%) 
Cough  1  3/16 (18.75%)  2/13 (15.38%) 
Dyspnea  1  4/16 (25.00%)  4/13 (30.77%) 
Hiccoughs  1  0/16 (0.00%)  1/13 (7.69%) 
Voice changes/dysarthria  1  0/16 (0.00%)  1/13 (7.69%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  1/16 (6.25%)  0/13 (0.00%) 
Alopecia  1  1/16 (6.25%)  2/13 (15.38%) 
Pruritis/itching  1  2/16 (12.50%)  3/13 (23.08%) 
Rash/desquamation  1  5/16 (31.25%)  5/13 (38.46%) 
Skin - other  1  1/16 (6.25%)  1/13 (7.69%) 
Vascular disorders     
Vascular - other  1  1/16 (6.25%)  0/13 (0.00%) 
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: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00101283     History of Changes
Other Study ID Numbers: CDR0000401795
U10CA021115 ( U.S. NIH Grant/Contract )
E1B03 ( Other Identifier: ECOG )
E1B03 ( Other Identifier: NCCTG )
First Submitted: January 7, 2005
First Posted: January 10, 2005
Results First Submitted: February 12, 2010
Results First Posted: March 4, 2010
Last Update Posted: December 4, 2012