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.

Study Overview

• Status: Withdrawn
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: Pemetrexed; Drug: Ixabepilone

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Los Angeles County+University of Southern California Medical Center
    • Los Angeles, California, United States, 90033
      • USC/Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Escalating doses of Ixabepilone and Pemetrexed	Drug: Pemetrexed; Drug: Ixabepilone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the maximal tolerated dose (MTD) of Ixabepilone and Pemetrexed in advanced solid tumors.	weekly

Secondary Outcome Measures

Outcome Measure	Time Frame
Response Rate	every 42 days

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Agustin Garcia, MD, Univrsity of Southern California

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: November 4, 2009
• First Submitted That Met QC Criteria: July 23, 2010
• First Posted (Estimate): July 27, 2010

Study Record Updates

• Last Update Posted (Estimate): May 21, 2014
• Last Update Submitted That Met QC Criteria: May 19, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Pemetrexed
• Other Study ID Numbers: 0C-08-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No