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This study has been withdrawn prior to enrollment.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

November 4, 2009
May 19, 2014
Not Provided
Not Provided
To determine the maximal tolerated dose (MTD) of Ixabepilone and Pemetrexed in advanced solid tumors. [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01170871 on ClinicalTrials.gov Archive Site
Response Rate [ Time Frame: every 42 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ixabepilone and Pemetrexed/Solid Tumors
Phase I Clinical Trial of Ixabepilone and Pemetrexed in Advanced Solid Tumors

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
  • Drug: Ixabepilone
  • Drug: Pemetrexed
Experimental: Experimental
Escalating doses of Ixabepilone and Pemetrexed
Interventions:
  • Drug: Ixabepilone
  • Drug: Pemetrexed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01170871
0C-08-2
No
Agustin Garcia, MD, University of Southern California
University of Southern California
Not Provided
Principal Investigator: Agustin Garcia, MD Univrsity of Southern California
University of Southern California
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP