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Sorafenib Combined With Cisplatin and Etoposide or Carboplatin and Pemetrexed in Treating Patients With Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT00573690
Recruitment Status : Completed
First Posted : December 14, 2007
Last Update Posted : April 24, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Description
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Brief Summary:

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, etoposide, and carboplatin, 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 cisplatin and etoposide or carboplatin and pemetrexed may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when given together with cisplatin and etoposide or carboplatin and pemetrexed in treating patients with metastatic solid tumors.


Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: carboplatin Drug: cisplatin Drug: etoposide Drug: pemetrexed disodium Drug: sorafenib tosylate Phase 1

Detailed Description:

OBJECTIVES:

Primary

  • To determine the recommended phase II dose and maximum tolerated dose of sorafenib tosylate when administered in combination with cisplatin and etoposide or carboplatin and pemetrexed disodium in patients with metastatic solid tumors.

Secondary

  • To characterize the toxicities of these regimens in these patients.
  • To evaluate the efficacy of these regimens in these patients, as measured by RECIST criteria or by tumor markers, if applicable (e.g., PSA, CA-125).
  • To determine the pharmacokinetics of sorafenib tosylate when administered in combination with etoposide in these patients (samples are no longer being collected and studies are no longer being performed as of 1/8/09).

OUTLINE: Patients are assigned to 1 of 2 treatment groups.

  • Group 1: Patients receive cisplatin IV over 1 hour on day 2 of courses 1 and 2 and on day 1 of all subsequent courses; etoposide IV over 30 minutes on days 1-3; and oral sorafenib tosylate once or twice daily on days 1-21. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression.
  • Group 2: Patients receive carboplatin IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Patients also receive sorafenib tosylate as in group 1. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression.

Patients in group 1 undergo blood sample collection on day 1 of courses 1 and 2 for pharmacokinetic studies (samples are no longer being collected and studies are no longer being performed as of 1/8/09).

After finishing treatment, patients are followed at 30 days.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two Arm Phase I Trial of Sorafenib in Combination With Cisplatin/Etoposide or Carboplatin/Pemetrexed in Patients With Solid Tumors
Study Start Date : September 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
Patients receive cisplatin IV over 1 hour on day 2 of courses 1 and 2 and on day 1 of all subsequent courses; etoposide IV over 30 minutes on days 1-3; and oral sorafenib tosylate once or twice daily on days 1-21. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression.
 Drug: cisplatin
Given IV

Drug: etoposide
Given IV

Drug: sorafenib tosylate
Given orally
Experimental: Group 2
Patients receive carboplatin IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Patients also receive sorafenib tosylate as in group 1. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression.
 Drug: carboplatin
Given IV

Drug: pemetrexed disodium
Given IV

Drug: sorafenib tosylate
Given orally


Outcome Measures
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Primary Outcome Measures :
  1. Recommended phase II dose and maximum tolerated dose of sorafenib tosylate when administered in combination with cisplatin and etoposide or carboplatin and pemetrexed disodium [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 12 months ]
  2. Efficacy of treatment as measured by RECIST criteria or by tumor markers [ Time Frame: 36 months ]
  3. Pharmacokinetics of sorafenib tosylate in combination with etoposide (samples are no longer being collected and studies are no longer being performed as of 1/8/09) [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed metastatic solid tumor

    • Disease progressed during at least one standard therapy OR has a disease for which there is no standard therapy
  • No squamous cell carcinoma of the lung

  • Asymptomatic brain metastases allowed provided both of the following criteria are met:

    • Brain metastases were treated ≥ 6 months ago
    • Brain metastases are clinically stable without steroid treatment for 1 week
  • No clinically relevant pleural effusions or ascites that cannot be controlled by drainage (group 2)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Hemoglobin ≥ 9.0 g/dL
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 times ULN
  • INR < 1.5 or PT/PTT normal
  • Creatinine clearance ≥ 45 mL/min
  • Negative serum pregnancy test
  • Fertile patients must use effective contraception during and for at least 2 weeks after completion of study treatment
  • No New York Heart Association class III or 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 > 150 mm Hg or diastolic blood pressure > 90 mm Hg, despite optimal medical management
  • No known severe hypersensitivity to sorafenib tosylate or any its excipients, etoposide, pemetrexed disodium, cisplatin, or carboplatin
  • No known HIV infection
  • No chronic hepatitis B or C
  • No active clinically serious infection > CTCAE grade 2
  • No thrombotic or embolic events, such as cerebrovascular accident or transient ischemic attacks, within the past 6 months
  • No pulmonary hemorrhage or bleeding event ≥ CTCAE grade 2 within the past 4 weeks
  • No other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks
  • No serious non-healing wound, ulcer, or bone fracture
  • No evidence or history of bleeding diathesis or coagulopathy
  • No condition that impairs the patient's ability to swallow whole pills
  • No malabsorption problem, uncontrolled inflammatory bowel disease, or gastrointestinal disorder causing ≥ 5 bowel movements in a 24-hour period
  • No significant traumatic injury within the past 4 weeks
  • Able to take vitamin B12 supplementation and folic acid (group 2)

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior major surgery or open biopsy
  • No more than 3 prior cytotoxic therapies for metastatic disease
  • No concurrent St. John's wort or rifampin
  • No non-steroidal anti-inflammatory drugs (NSAIDs) for 2 days before (5 days for long-acting NSAIDs), during, and for 2 days after pemetrexed disodium administration (group 2)
  • Concurrent anticoagulation treatment with warfarin or heparin allowed
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573690


Locations
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United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Thomas E. Stinchcombe, MD UNC Lineberger Comprehensive Cancer Center
Principal Investigator: Elizabeth C. Dees, MD UNC Lineberger Comprehensive Cancer Center
More Information
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00573690    
Other Study ID Numbers: LCCC 0613
CDR0000579819 ( Other Identifier: NCI PDQ number )
UNC-LCC-07-0971
First Posted: December 14, 2007    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: April 2012
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Neoplasms
Carboplatin
Etoposide
Pemetrexed
Sorafenib
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
 Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors