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

This study has been completed.

Sponsor:

Collaborators:

National Cancer Institute (NCI)

North Central Cancer Treatment Group

Information provided by (Responsible Party):

Eastern Cooperative Oncology Group

ClinicalTrials.gov Identifier:

NCT00101283

First received: January 7, 2005

Last updated: November 30, 2012

Last verified: November 2012

History of Changes

Results First Received: February 12, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Mesothelioma
Interventions:	Drug: pemetrexed disodium Drug: gemcitabine hydrochloride Drug: carboplatin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Pemetrexed/Carboplatin	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/Gemcitabine	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.

Participant Flow: Overall Study

	Pemetrexed/Carboplatin	Pemetrexed/Gemcitabine
STARTED	16	16
Began Treatment	16	13
COMPLETED	16	13
NOT COMPLETED	0	3
Withdrawal by Subject	0	1
Insurance Refusal	0	1
Prostate Cancer Recurrence	0	1

Baseline Characteristics

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Reporting Groups

	Description
Pemetrexed/Carboplatin	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/Gemcitabine	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	Total of all reporting groups

Baseline Measures

	Pemetrexed/Carboplatin	Pemetrexed/Gemcitabine	Total
Number of Participants [units: participants]	16	13	29
Age [units: years] Median ( Full Range )	72 ( 55 to 78 )	68 ( 53 to 80 )	71 ( 53 to 80 )
Gender ^[1] [units: participants]
Female	2	12	14
Male	14	1	15

[1]	Gender of participants who began treatment.

Outcome Measures

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1. Primary:

Best Overall Response by RECIST Criteria (Version 1.0) [ 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 ]

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2. Secondary:

Overall Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 1 year ]

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3. Secondary:

Progression-Free Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 1 year ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	Assessed every cycle (21 days) while on treatment and for 30 days after the end of treatment.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Pemetrexed/Carboplatin	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/Gemcitabine	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.

Other Adverse Events

	Pemetrexed/Carboplatin	Pemetrexed/Gemcitabine
Total, other (not including serious) adverse events
# participants affected / at risk	16/16	13/13
Blood and lymphatic system disorders
Anemia ^{† 1}
# participants affected / at risk	14/16 (87.50%)	12/13 (92.31%)
Hemolysis ^{† 1}
# participants affected / at risk	0/16 (0.00%)	1/13 (7.69%)
Leukopenia ^{† 1}
# participants affected / at risk	13/16 (81.25%)	11/13 (84.62%)
Lymphopenia ^{† 1}
# participants affected / at risk	2/16 (12.50%)	1/13 (7.69%)
Neutropenia ^{† 1}
# participants affected / at risk	11/16 (68.75%)	8/13 (61.54%)
Thrombocytopenia ^{† 1}
# participants affected / at risk	9/16 (56.25%)	7/13 (53.85%)
Edema, limb ^{† 1}
# participants affected / at risk	0/16 (0.00%)	3/13 (23.08%)
Ear and labyrinth disorders
Hearing loss (without baseline audiogram, not in monitoring program) ^{† 1}
# participants affected / at risk	1/16 (6.25%)	0/13 (0.00%)
Endocrine disorders
Hot flashes ^{† 1}
# participants affected / at risk	1/16 (6.25%)	0/13 (0.00%)
Eye disorders
Tearing ^{† 1}
# participants affected / at risk	1/16 (6.25%)	0/13 (0.00%)
Ocular - other ^{† 1}
# participants affected / at risk	1/16 (6.25%)	0/13 (0.00%)
Gastrointestinal disorders
Anorexia ^{† 1}
# participants affected / at risk	5/16 (31.25%)	9/13 (69.23%)
Constipation ^{† 1}
# participants affected / at risk	6/16 (37.50%)	5/13 (38.46%)
Dehydration ^{† 1}
# participants affected / at risk	0/16 (0.00%)	2/13 (15.38%)
Diarrhea w/o prior colostomy ^{† 1}
# participants affected / at risk	3/16 (18.75%)	2/13 (15.38%)
Distention/bloating, abdominal ^{† 1}
# participants affected / at risk	0/16 (0.00%)	2/13 (15.38%)
Dry mouth ^{† 1}
# participants affected / at risk	1/16 (6.25%)	0/13 (0.00%)
Muco/stomatitis (symptom), oral cavity ^{† 1}
# participants affected / at risk	0/16 (0.00%)	1/13 (7.69%)
Muco/stomatitis (symptom), pharynx ^{† 1}
# participants affected / at risk	5/16 (31.25%)	2/13 (15.38%)
Nausea ^{† 1}
# participants affected / at risk	9/16 (56.25%)	4/13 (30.77%)
Taste disturbance ^{† 1}
# participants affected / at risk	3/16 (18.75%)	3/13 (23.08%)
Vomiting ^{† 1}
# participants affected / at risk	3/16 (18.75%)	4/13 (30.77%)
GI - other ^{† 1}
# participants affected / at risk	0/16 (0.00%)	1/13 (7.69%)
Colitis, infectious ^{† 1}
# participants affected / at risk	1/16 (6.25%)	0/13 (0.00%)
Abdomen, pain ^{† 1}
# participants affected / at risk	1/16 (6.25%)	0/13 (0.00%)
General disorders
Fatigue ^{† 1}
# participants affected / at risk	15/16 (93.75%)	12/13 (92.31%)
Fever w/o neutropenia ^{† 1}
# participants affected / at risk	3/16 (18.75%)	3/13 (23.08%)
Insomnia ^{† 1}
# participants affected / at risk	1/16 (6.25%)	3/13 (23.08%)
Rigors/chills ^{† 1}
# participants affected / at risk	2/16 (12.50%)	1/13 (7.69%)
Sweating ^{† 1}
# participants affected / at risk	1/16 (6.25%)	1/13 (7.69%)
Weight gain ^{† 1}
# participants affected / at risk	1/16 (6.25%)	1/13 (7.69%)
Weight loss ^{† 1}
# participants affected / at risk	3/16 (18.75%)	5/13 (38.46%)
Hepatobiliary disorders
Liver, pain ^{† 1}
# participants affected / at risk	0/16 (0.00%)	1/13 (7.69%)
Immune system disorders
Allergic rhinitis ^{† 1}
# participants affected / at risk	1/16 (6.25%)	0/13 (0.00%)
Infections and infestations
Infection w/ gr 0-2 neutrophils, sinus ^{† 1}
# participants affected / at risk	2/16 (12.50%)	0/13 (0.00%)
Investigations
Elevated ALT, SGPT (serum glutamic pyruvic transaminase) ^{† 1}
# participants affected / at risk	5/16 (31.25%)	6/13 (46.15%)
Elevated AST, SGOT (serum glutamic oxaloacetic transaminase) ^{† 1}
# participants affected / at risk	3/16 (18.75%)	6/13 (46.15%)
Elevated creatinine ^{† 1}
# participants affected / at risk	1/16 (6.25%)	2/13 (15.38%)
Metabolism and nutrition disorders
Hypoalbuminemia ^{† 1}
# participants affected / at risk	3/16 (18.75%)	11/13 (84.62%)
Elevated alkaline phosphatase ^{† 1}
# participants affected / at risk	3/16 (18.75%)	9/13 (69.23%)
Elevated bilirubin ^{† 1}
# participants affected / at risk	1/16 (6.25%)	2/13 (15.38%)
Hyperglycemia ^{† 1}
# participants affected / at risk	4/16 (25.00%)	2/13 (15.38%)
Hemoglobinuria ^{† 1}
# participants affected / at risk	0/16 (0.00%)	1/13 (7.69%)
Hyponatremia ^{† 1}
# participants affected / at risk	1/16 (6.25%)	0/13 (0.00%)
Musculoskeletal and connective tissue disorders
Arthritis ^{† 1}
# participants affected / at risk	0/16 (0.00%)	1/13 (7.69%)
Musculoskeletal/soft tissue - other ^{† 1}
# participants affected / at risk	0/16 (0.00%)	1/13 (7.69%)
Bone, pain ^{† 1}
# participants affected / at risk	1/16 (6.25%)	0/13 (0.00%)
Extremity - limb, pain ^{† 1}
# participants affected / at risk	0/16 (0.00%)	1/13 (7.69%)
Joint, pain ^{† 1}
# participants affected / at risk	0/16 (0.00%)	1/13 (7.69%)
Muscle, pain ^{† 1}
# participants affected / at risk	2/16 (12.50%)	2/13 (15.38%)
Nervous system disorders
Dizziness ^{† 1}
# participants affected / at risk	1/16 (6.25%)	2/13 (15.38%)
Depression ^{† 1}
# participants affected / at risk	0/16 (0.00%)	1/13 (7.69%)
Neuropathy, sensory ^{† 1}
# participants affected / at risk	1/16 (6.25%)	1/13 (7.69%)
Renal and urinary disorders
Urinary frequency/urgency ^{† 1}
# participants affected / at risk	0/16 (0.00%)	1/13 (7.69%)
Respiratory, thoracic and mediastinal disorders
Chest/thoracic pain ^{† 1}
# participants affected / at risk	1/16 (6.25%)	0/13 (0.00%)
Cough ^{† 1}
# participants affected / at risk	3/16 (18.75%)	2/13 (15.38%)
Dyspnea ^{† 1}
# participants affected / at risk	4/16 (25.00%)	4/13 (30.77%)
Hiccoughs ^{† 1}
# participants affected / at risk	0/16 (0.00%)	1/13 (7.69%)
Voice changes/dysarthria ^{† 1}
# participants affected / at risk	0/16 (0.00%)	1/13 (7.69%)
Skin and subcutaneous tissue disorders
Dry skin ^{† 1}
# participants affected / at risk	1/16 (6.25%)	0/13 (0.00%)
Alopecia ^{† 1}
# participants affected / at risk	1/16 (6.25%)	2/13 (15.38%)
Pruritis/itching ^{† 1}
# participants affected / at risk	2/16 (12.50%)	3/13 (23.08%)
Rash/desquamation ^{† 1}
# participants affected / at risk	5/16 (31.25%)	5/13 (38.46%)
Skin - other ^{† 1}
# participants affected / at risk	1/16 (6.25%)	1/13 (7.69%)
Vascular disorders
Vascular - other ^{† 1}
# participants affected / at risk	1/16 (6.25%)	0/13 (0.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, CTCAE (3.0)

More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012

No publications provided

Responsible Party:	Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00101283 History of Changes
Other Study ID Numbers:	CDR0000401795, U10CA021115, E1B03, E1B03
Study First Received:	January 7, 2005
Results First Received:	February 12, 2010
Last Updated:	November 30, 2012
Health Authority:	United States: Federal Government

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