Ixabepilone and Pemetrexed/Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01170871
Recruitment Status : Withdrawn (Sponsor withdrew support)
First Posted : July 27, 2010
Last Update Posted : May 21, 2014
Information provided by:
University of Southern California

Brief Summary:

The purpose of the study is to determine the maximal tolerated dose (MTD) of Ixabepilone and Pemetrexed in advanced solid tumors and to obtain preliminary information regarding the activity of this combination.

This research study is for research participants who have confirmed metastatic or unresectable solid tumors (lung, breast, ovary, cervix, uterus, mesothelioma, and prostate) for which standard curative or palliative measures do not exist or no longer effective.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Ixabepilone Drug: Pemetrexed Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial of Ixabepilone and Pemetrexed in Advanced Solid Tumors

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Experimental
Escalating doses of Ixabepilone and Pemetrexed
Drug: Ixabepilone
Drug: Pemetrexed

Primary Outcome Measures :
  1. To determine the maximal tolerated dose (MTD) of Ixabepilone and Pemetrexed in advanced solid tumors. [ Time Frame: weekly ]

Secondary Outcome Measures :
  1. Response Rate [ Time Frame: every 42 days ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • SWOG performance status of 0-2.
  • Projected life expectancy of at least 3 months.
  • Female and or male age 18 years and over.
  • Provision of informed consent prior to any study-related procedures.
  • Female patients must not be pregnant due to the potential mutagenicity. and teratogenicity of this treatment. A pregnancy test must be administered 7 days prior to administration of therapy to women of childbearing potential.
  • Negative pregnancy test for women of childbearing potential.
  • Patients must agree to use some form of contraception while on this study at initiation and for the duration of participation in the study. Sexually active males must also use a reliable and appropriate method of contraception. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Patients must have recovered from acute toxicities from previous surgery, chemotherapy or radiation therapy.
  • Adequate organ function defined as:

    • ANC > 1500/mm3
    • Platelet count > 100,000 cells/mm3
    • Hemoglobin > 9.0g/dL
    • Serum creatinine < 1.5 mg/dl or creatinine clearance > 45 mL/minute
    • (calculated by Cockcroft-Gault formula.)
    • Hepatic function: Patients must have adequate liver functions: AST or ALT < 2.5 X upper limit of normal (ULN), alkaline phosphatase < 2.5 X upper limit of normal. In patients with bone metastasis and no evidence of liver metastasis and bilirubin < upper limit of normal an alkaline phosphatase < 5 ULN will be allowed
    • Serum Bilirubin < 1.5 mg/dL
  • Peripheral neuropathy grade 0-1.
  • No other concomitant therapy directed at the cancer is allowed.
  • The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed.
  • The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.

Exclusion Criteria:

  • Laboratory results:

    • Serum bilirubin > 1.5 the upper limit of reference range (ULRR)
    • Serum creatinine >1.5 x ULRR or creatinine clearance < 45 mL/minute (calculated by Cockcroft-Gault formula)
  • Women who are currently pregnant or breast feeding.
  • Receipt of any investigational agents within 30 days prior to commencing study treatment.
  • Last dose of prior chemotherapy discontinued less than 4 weeks before the start of study therapy.
  • Last radiation therapy within the last 4 weeks before the start of study therapy, except palliative radiotherapy.
  • Prior radiation must not have included ≥ 30% of major bone marrow containing areas (pelvis, lumbar spine).
  • Any unresolved toxicity greater than CTC grade 1 from previous anti- cancer therapy, excluding alopecia.
  • CTC Grade 1 or greater neuropathy (motor or sensory) at study entry.
  • Hematologic function with absolute neutrophils ≤ 1500/mm3 and/or platelets < 100,000/mm 3.
  • Hepatic function with serum bilirubin greater than the upper institutional limits of normal, ALT and AST > 2.5 times the upper institutional limits of normal.
  • Presence of third space fluid which cannot be controlled by drainage.

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 identifier (NCT number): NCT01170871

United States, California
Los Angeles County+University of Southern California Medical Center
Los Angeles, California, United States, 90033
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Principal Investigator: Agustin Garcia, MD Univrsity of Southern California

Responsible Party: Agustin Garcia, MD, University of Southern California Identifier: NCT01170871     History of Changes
Other Study ID Numbers: 0C-08-2
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators