S9810: Gemcitabine Plus Cisplatin in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot Be Removed by Surgery
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: gemcitabine hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Gemcitabine and Cisplatin in Unresectable Malignant Mesothelioma |
- Estimate overall survival [ Time Frame: monthly while patient on treatment. Once off treatment every 6 months ] [ Designated as safety issue: No ]
- qualitative and quantitative toxicities [ Time Frame: week 1, 2, 3 (q 28 days) ] [ Designated as safety issue: Yes ]
- confirmed and unconfirmed complete and partial response [ Time Frame: every 8 weeks until progression ] [ Designated as safety issue: No ]
| Enrollment: | 57 |
| Study Start Date: | February 1999 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
Drug: gemcitabine hydrochloride
Gemcitabine 1000 mg/m^2 days 1, 8 15 (q 28 days)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 84 Study Locations| Study Chair: | Robert N. Taub, MD, PhD | Herbert Irving Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00003723 History of Changes |
| Other Study ID Numbers: | CDR0000066832, SWOG-S9810, U10CA032102 |
| Study First Received: | November 1, 1999 |
| Last Updated: | October 5, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
advanced malignant mesothelioma epithelial mesothelioma sarcomatous mesothelioma |
Additional relevant MeSH terms:
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Gemcitabine Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 18, 2013