Ixabepilone and Pemetrexed/Solid Tumors

This study has been withdrawn prior to enrollment.
(Sponsor withdrew support)
Sponsor:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT01170871
First received: November 4, 2009
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Advanced Solid Tumors
Drug: Ixabepilone
Drug: Pemetrexed
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial of Ixabepilone and Pemetrexed in Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • To determine the maximal tolerated dose (MTD) of Ixabepilone and Pemetrexed in advanced solid tumors. [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response Rate [ Time Frame: every 42 days ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
Experimental: Experimental
Escalating doses of Ixabepilone and Pemetrexed
Drug: Ixabepilone Drug: Pemetrexed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170871

Locations
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
Investigators
Principal Investigator: Agustin Garcia, MD Univrsity of Southern California
  More Information

No publications provided

Responsible Party: Agustin Garcia, MD, University of Southern California
ClinicalTrials.gov Identifier: NCT01170871     History of Changes
Other Study ID Numbers: 0C-08-2
Study First Received: November 4, 2009
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Pemetrexed
Epothilones
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 15, 2014