Capecitabine in Treating Patients With Malignant Mesothelioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have malignant mesothelioma.
Checked against the public recordLast updated Jul 14, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Drug: capecitabine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
DISEASE CHARACTERISTICS: Histologically proven malignant mesothelioma not amenable to potentially curative radiotherapy or surgery Epithelial, sarcomatoid, or mixed subtype Any site of origin allowed including, but not limited to, the following: Pleura Peritoneum Pericardium Tunica vaginalis Measurable disease At least one lesion accurately measured in at least one dimension Lesion at least 20 mm at largest diameter with conventional techniques or at least 10 mm with spiral CT scan The following are not considered measurable disease: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Tumor lesions located in a previously irradiated area PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception No active second malignancy except nonmelanomatous skin cancer Not considered an active second malignancy if: Therapy has been completed Less than 30% risk of relapse according to the physician No malabsorption syndrome PRIOR CONCURRENT THERAPY: Biologic therapy: Concurrent epoetin alfa allowed Chemotherapy: No prior systemic cytotoxic chemotherapy for malignant mesothelioma Prior intrapleural cytotoxic or sclerosing agents (including bleomycin) allowed No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except the following: Steroids administered for adrenal failure Hormonal therapy administered for nonmalignant conditions (e.g., insulin for diabetes) Intermittent use of dexamethasone as an antiemetic Radiotherapy: At least 4 weeks since prior radiotherapy Prior irradiation of symptomatic lesion allowed if there is other measurable disease outside the radiation port No concurrent radiotherapy Surgery: At least 2 weeks since prior major surgery Other: No concurrent leucovorin calcium or folinic acid
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Veterans Affairs Medical Center - BirminghamBirmingham, Alabama
- University of California San Diego Cancer CenterLa Jolla, California
- Veterans Affairs Medical Center - San FranciscoSan Francisco, California
- UCSF Cancer Center and Cancer Research InstituteSan Francisco, California
- CCOP - Christiana Care Health ServicesWilmington, Delaware
- Lombardi Cancer CenterWashington D.C., District of Columbia
- Walter Reed Army Medical CenterWashington D.C., District of Columbia
- CCOP - Mount Sinai Medical CenterMiami Beach, Florida
- University of Illinois at Chicago Health Sciences CenterChicago, Illinois
- Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois
- University of Chicago Cancer Research CenterChicago, Illinois
- Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 14, 2016. Always confirm current availability with the study team.