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S9810: Gemcitabine Plus Cisplatin in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot Be Removed by Surgery

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: NCT00003723
Recruitment Status : Completed
First Posted : June 24, 2004
Last Update Posted : October 8, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE June 24, 2004
Last Update Posted Date October 8, 2012
Study Start Date  ICMJE February 1999
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2011)
Estimate overall survival [ Time Frame: monthly while patient on treatment. Once off treatment every 6 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00003723 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2011)
  • qualitative and quantitative toxicities [ Time Frame: week 1, 2, 3 (q 28 days) ]
  • confirmed and unconfirmed complete and partial response [ Time Frame: every 8 weeks until progression ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S9810: Gemcitabine Plus Cisplatin in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot Be Removed by Surgery
Official Title  ICMJE Phase II Study of Gemcitabine and Cisplatin in Unresectable Malignant Mesothelioma
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients with malignant mesothelioma of the pleura that cannot be removed by surgery.

Detailed Description

OBJECTIVES: I. Estimate overall survival and confirmed and unconfirmed complete and partial response in patients with unresectable malignant mesothelioma of the pleura treated with gemcitabine plus cisplatin. II. Evaluate the qualitative and quantitative toxicities of this regimen in this patient population.

OUTLINE: Patients receive gemcitabine IV over 30 minutes, immediately followed by cisplatin IV over 30 minutes on days 1, 8, and 15. Courses are repeated every 28 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients with a complete response receive 2 additional courses of therapy. Patients are followed every 6 months until death.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 25 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Mesothelioma
Intervention  ICMJE Drug: gemcitabine hydrochloride
Gemcitabine 1000 mg/m^2 days 1, 8 15 (q 28 days)
Study Arms  ICMJE Experimental: Gemcitabine/Cisplatin
Gemcitabine 1000 mg/m^2 days 1, 8 15 (q 28 days) cisplatin 30 mg/m^2 days 1, 8, 15 (q 28 days)
Intervention: Drug: gemcitabine hydrochloride
Publications * Kalmadi SR, Rankin C, Kraut MJ, Jacobs AD, Petrylak DP, Adelstein DJ, Keohan ML, Taub RN, Borden EC. Gemcitabine and cisplatin in unresectable malignant mesothelioma of the pleura: a phase II study of the Southwest Oncology Group (SWOG 9810). Lung Cancer. 2008 May;60(2):259-63. Epub 2007 Nov 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2012)
57
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of unresectable malignant mesothelioma of the pleura Epithelial, fibrosarcomatous, or mixed type Bidimensionally measurable disease No CNS metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least lower limit of normal Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 2 times ULN AND Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission Must have chest x-ray within the past 28 days

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Concurrent hormones for non-disease-related conditions allowed Concurrent steroids for antiemesis, adrenal failure, or septic shock allowed Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003723
Other Study ID Numbers  ICMJE CDR0000066832
SWOG-S9810 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Southwest Oncology Group
Study Sponsor  ICMJE Southwest Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Robert N. Taub, MD, PhD Herbert Irving Comprehensive Cancer Center
PRS Account Southwest Oncology Group
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP