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Sorafenib, Pemetrexed, and Cisplatin in Treating Patients With Advanced Solid Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: June 20, 2008,Last Updated: June 16, 2009,History of Changes
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
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.
Resource links provided by NLM:
Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Head and Neck Cancer Lung Cancer Mesothelioma Pancreatic Cancer Prostate Cancer Salivary Gland Disorders Soft Tissue Sarcoma Tonsils and Adenoids
Drug Information available for: Cisplatin Pemetrexed Pemetrexed disodium Sorafenib Sorafenib tosylate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
  • Maximum tolerated dose of sorafenib tosylate [ Designated as safety issue: Yes ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Disease response as assessed by RECIST criteria [ Designated as safety issue: No ]
Estimated Enrollment: 12
Study Start Date: May 2008
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of sorafenib tosylate when given in combination with pemetrexed disodium and cisplatin in patients with advanced non-squamous cell solid tumor malignancy including, but not limited to, breast, lung, colon, pancreatic, prostate, or head and neck cancer or sarcoma.

Secondary

  • To characterize the quantitative and qualitative toxicities of this regimen in these patients.
  • To obtain preliminary information about the antitumor activity of this regimen in these patients.

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
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-hematologic malignancy including, but not limited to, any of the following:

    • Breast cancer
    • Lung cancer
    • Colon cancer
    • Pancreatic cancer
    • Prostate cancer
    • Head and neck cancer
    • Sarcoma
  • No squamous cell lung cancer
  • Advanced disease

    • Must have failed or become intolerant to prior standard therapy and is no longer likely to respond to such therapy

      • Patients with mesothelioma do not have to meet prior therapy requirements in order to be enrolled on the study since the combination of cisplatin and pemetrexed disodium is considered current standard first-line therapy for mesothelioma
  • Measurable or nonmeasurable disease as defined by RECIST criteria
  • Previously treated stable brain metastases allowed
  • No clinically significant third-space fluid, such as pleural effusion or ascites

    • Third-space fluid allowed provided it can be completely drained
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • ECOG performance status 0-2
  • ANC = 1.5 x 10^9/L
  • Platelet count = 100 x 10^9/L
  • Hemoglobin = 9 g/dL
  • Bilirubin = 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase = 3 times ULN (5 times ULN if liver has tumor involvement)
  • AST and ALT = 3 times ULN (5 times ULN if liver has tumor involvement)
  • Serum creatinine = 1.5 mg/dL
  • Creatinine clearance > 45 mL/min
  • INR < 1.5 OR PT/PTT normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 2 weeks after completion of study treatment
  • Able to take folic acid and vitamin B_12
  • Able to take oral medications without crushing, dissolving, or chewing tablets
  • No malabsorption problem
  • No other condition that impairs the patient's ability to swallow whole pills
  • No New York Heart Association class III-IV congestive heart failure
  • No unstable angina (anginal symptoms at rest) or new onset angina within the past 3 months
  • No myocardial infarction within the past 6 months
  • No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg despite optimal medical management
  • No thrombolic or embolic events, such as cerebrovascular accident or transient ischemic attacks, within the past 6 months
  • No pulmonary hemorrhage/bleeding event = CTCAE grade 2 within the past 4 weeks
  • No other hemorrhage/bleeding event = CTCAE grade 3 within the past 4 weeks
  • No evidence or history of bleeding diathesis or coagulopathy
  • No known or suspected allergy to sorafenib tosylate, pemetrexed disodium, cisplatin, or any agent given in the course of this study
  • No known HIV infection or chronic hepatitis B or C infection
  • No active clinically serious infection > CTCAE grade 2
  • No serious nonhealing wound, ulcer, or bone fracture
  • No significant traumatic injury within the past 4 weeks
  • No peripheral neuropathy = CTCAE grade 2
  • No second primary malignancy except in situ carcinoma of the cervix or breast or other in situ malignancies, adequately treated basal cell carcinoma of the skin, or other malignancy treated at least 3 years ago with no evidence of recurrence

PRIOR CONCURRENT THERAPY:

  • At least 3 weeks since prior systemic therapy (6 weeks for bevacizumab) and recovered
  • At least 3 months since prior pemetrexed disodium or cisplatin
  • No prior sorafenib tosylate
  • More than 4 weeks since prior major surgery or open biopsy
  • No NSAIDs or salicylates for 2 days before, during, and for 2 days after pemetrexed disodium administration

    • No NSAIDs or salicylates with a long half-life (e.g., naproxen, piroxicam, diflunisal, albumetone) for 5 days before, during, and for 2 days after pemetrexed disodium administration
  • No concurrent Hypericum perforatum (St. John's wort) or rifampin
  • Concurrent anti-coagulation treatment with warfarin or heparin allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703638
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
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Priya Kumar, MD Masonic Cancer Center, University of Minnesota
More Information Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ database :
http://www.cancer.gov/clinicaltrials/UMN-2007LS086
No publications provided
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
Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma recurrent malignant mesothelioma 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
Study placed in the following topic categories:
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
Additional relevant MeSH terms:
Mesothelioma 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
ClinicalTrials.gov processed this record on July 31, 2009 Source: http://www.clinicaltrials.gov

Source: http://www.clinicaltrials.gov