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| Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00703638 |
Purpose
RATIONALE: Sorafenib and pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with pemetrexed and cisplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when given together with pemetrexed and cisplatin in treating patients with advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Colorectal Cancer Head and Neck Cancer Lung Cancer Malignant Mesothelioma Pancreatic Cancer Prostate Cancer Sarcoma |
Drug: cisplatin Drug: pemetrexed disodium Drug: sorafenib tosylate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study of Sorafenib, Pemetrexed, and Cisplatin for the Treatment of Advanced Solid Tumors. |
| Estimated Enrollment: | 12 |
| Study Start Date: | May 2008 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of sorafenib tosylate.
Patients receive oral sorafenib tosylate once daily on days 1-21 and cisplatin IV over 1-2 hours and pemetrexed disodium IV over 10 minutes on day 1.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days, every 8 weeks until disease progression, and then every 3 months for up to 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-hematologic malignancy including, but not limited to, any of the following:
Advanced disease
Must have failed or become intolerant to prior standard therapy and is no longer likely to respond to such therapy
No clinically significant third-space fluid, such as pleural effusion or ascites
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No NSAIDs or salicylates for 2 days before, during, and for 2 days after pemetrexed disodium administration
Contacts and Locations| United States, Minnesota | |
| Masonic Cancer Center at University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
| Principal Investigator: | Priya Kumar, MD | Masonic Cancer Center, University of Minnesota |
More Information
| Responsible Party: | Masonic Cancer Center at University of Minnesota ( Priya Kumar ) |
| Study ID Numbers: | CDR0000597879, UMN-2007LS086, 0712M22703, BAYER-UMN-2007LS086 |
| Study First Received: | June 20, 2008 |
| Last Updated: | June 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00703638 History of Changes |
| Health Authority: | Unspecified |
|
recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer male breast cancer recurrent non-small cell lung cancer recurrent small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer extensive stage small cell lung cancer recurrent pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer |
recurrent prostate cancer stage III prostate cancer stage IV prostate cancer recurrent adult soft tissue sarcoma stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma recurrent adenoid cystic carcinoma of the oral cavity recurrent mucoepidermoid carcinoma of the oral cavity stage III adenoid cystic carcinoma of the oral cavity stage III mucoepidermoid carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity stage IV mucoepidermoid carcinoma of the oral cavity recurrent basal cell carcinoma of the lip stage III basal cell carcinoma of the lip stage IV basal cell carcinoma of the lip |
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Thoracic Neoplasms Prostatic Diseases Pancreatic Neoplasms Colonic Diseases Urogenital Neoplasms Breast Cancer, Male Protein Kinase Inhibitors Rectal Diseases Neoplasms, Connective and Soft Tissue Carcinoma, Adenoid Cystic Lung Neoplasms Salivary Gland Diseases Breast Diseases Endocrine Gland Neoplasms Digestive System Neoplasms |
Breast Neoplasms Endocrine System Diseases Carcinoma, Basal Cell Genital Diseases, Male Carcinoma Folic Acid Carcinoma, Small Cell Pemetrexed Malignant Mesenchymal Tumor Breast Neoplasms, Male Lung Diseases Sarcoma Gastrointestinal Neoplasms Pancreatic Diseases Prostatic Neoplasms |
|
Thoracic Neoplasms Antimetabolites, Antineoplastic Prostatic Diseases Molecular Mechanisms of Pharmacological Action Pancreatic Neoplasms Colonic Diseases Physiological Effects of Drugs Urogenital Neoplasms Protein Kinase Inhibitors Rectal Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Site Lung Neoplasms Therapeutic Uses Breast Diseases |
Endocrine Gland Neoplasms Digestive System Neoplasms Breast Neoplasms Endocrine System Diseases Genital Diseases, Male Pemetrexed Neoplasms Lung Diseases Sarcoma Gastrointestinal Neoplasms Pancreatic Diseases Prostatic Neoplasms Neoplasms, Glandular and Epithelial Antimetabolites Genital Neoplasms, Male |