Clinical trial · Interventional
S9810: Gemcitabine Plus Cisplatin in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot Be Removed by Surgery
Phase II Study of Gemcitabine and Cisplatin in Unresectable Malignant Mesothelioma
NCT00003723CI-TRIAL-00008232completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Mesothelioma | Malignant Mesothelioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine/Cisplatin
- description
- Gemcitabine 1000 mg/m\^2 days 1, 8 15 (q 28 days) cisplatin 30 mg/m\^2 days 1, 8, 15 (q 28 days)
- interventionNames
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- Estimate overall survival
- timeFrame
- monthly while patient on treatment. Once off treatment every 6 months
Secondary outcomes (2)
- measure
- qualitative and quantitative toxicities
- timeFrame
- week 1, 2, 3 (q 28 days)
- measure
- confirmed and unconfirmed complete and partial response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTKalmadi 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. doi: 10.1016/j.lungcan.2007.09.018. Epub 2007 Nov 19. PMID 18006112