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Phase I Clinical Trial of Ixabepilone and Pemetrexed in Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

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Trial Information

Phase I Clinical Trial of Ixabepilone and Pemetrexed in Advanced Solid Tumors

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximal tolerated dose (MTD) of Ixabepilone and Pemetrexed in advanced solid tumors.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Agustin Garcia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Univrsity of Southern California


United States: Institutional Review Board

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms



USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Los Angeles County+University of Southern California Medical CenterLos Angeles, California  90033