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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), August 2008

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

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   

ChemIDplus related topics:   Cisplatin    Pemetrexed disodium    Pemetrexed    Sorafenib    Sorafenib tosylate    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Study of Sorafenib, Pemetrexed, and Cisplatin for the Treatment of Advanced Solid Tumors.

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
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Priya Kumar, MD     Masonic Cancer Center, University of Minnesota    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Masonic Cancer Center at University of Minnesota ( Priya Kumar )
Study ID Numbers:   CDR0000597879, UMN-2007LS086, 0712M22703, BAYER-UMN-2007LS086
First Received:   June 20, 2008
Last Updated:   September 22, 2008
ClinicalTrials.gov Identifier:   NCT00703638
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Prostatic Diseases
Pancreatic Neoplasms
Malignant mesenchymal tumor
Colonic Diseases
Urogenital Neoplasms
Rectal Diseases
Neoplasms, Connective and Soft Tissue
Carcinoma, Adenoid Cystic
Lung Neoplasms
Salivary Gland Diseases
Breast Diseases
Endocrine Gland Neoplasms
Non-small cell lung cancer
Digestive System Neoplasms
Breast Neoplasms
Endocrine System Diseases
Carcinoma, Basal Cell
Genital Diseases, Male
Carcinoma
Folic Acid
Pemetrexed
Carcinoma, Small Cell
Breast Neoplasms, Male
Lung Diseases
Sarcoma
Gastrointestinal Neoplasms
Pancreatic Diseases
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 07, 2008




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