Pemetrexed Disodium and Docetaxel in Treating Patients With Advanced Solid Tumors

December 2, 2015 updated by: University of Arizona

Phase I Dose Escalation Trial of Biweekly Alimta (With Vitamin Supplementation) in Combination With Taxotere in Advanced Solid Tumor Patients

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells of by stopping them from dividing. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of giving pemetrexed disodium and docetaxel together in treating patients with advanced solid tumors.

Study Overview

Detailed Description

OBJECTIVES:

Primary

  • To determine the maximum-tolerated dose of the combination of pemetrexed disodium and docetaxel when administered on a day 1 and day 15 dosing schedule.

Secondary

  • To specifically characterize the toxicity profile for the combination of biweekly pemetrexed disodium and docetaxel.
  • To investigate the antitumor activity in patients with advanced solid tumors as measured by RECIST criteria for patients with measurable disease or tumor markers for patients with non-measurable disease.
  • To determine the recommended phase II dose of the combination of pemetrexed disodium and docetaxel on a biweekly dosing schedule.

OUTLINE: This is a dose-escalation study.

Patients receive pemetrexed disodium IV over 10 minutes and docetaxel IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Tucson, Arizona, United States, 85724-5024
        • Arizona Cancer Center at University of Arizona Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of advanced or recurrent solid tumors

    • Patients for whom docetaxel is considered appropriate anticancer therapy; docetaxel is currently approved for use in patients with the following solid tumors:

      • Non-small cell lung (NSCLC)
      • Breast
      • Prostate
      • Esophageal
      • Head and neck
      • Ovarian
      • Gastric
  • Measurable or non-measurable disease
  • No squamous cell NSCLC
  • Controlled brain metastases allowed

    • Clinically stable with no signs of progression by MRI or CAT scan ≥ 60 days after treatment
    • Patients must be asymptomatic with no steroid requirements

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 12 weeks
  • WBC ≥ 3,000/mm^3*
  • ANC ≥ 1,500/mm^3*
  • Hemoglobin ≥ 9 g/dL
  • Platelet count ≥ 100,000/mm^3
  • Total bilirubin normal
  • AST, ALT, and alkaline phosphatase (AP) must meet one of the following criteria:

    • AST or ALT ≤ 3** times upper limit of normal (ULN) AND AP normal
    • AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN
    • AST or ALT normal AND AP ≤ 5 times ULN
  • Calculated creatinine clearance ≥ 45 mL/min OR GFR measured by Tc99m-DPTA serum clearance method
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • Able to interrupt aspirin or other NSAIDs pre- and post- twice-monthly drug dosing
  • Able to take folic acid, vitamin B12, or corticosteroids
  • No uncontrolled serious active infections
  • No pre-existing peripheral neuropathy > grade 1
  • No significant cardiac disease (i.e., uncontrolled high blood pressure, unstable angina, congestive heart failure within the past 6 months, LVEF < normal, myocardial infarction within the past year, or serious cardiac arrhythmias requiring medication)
  • No known severe hypersensitivity reaction to docetaxel or other drugs formulated in polysorbate 80 NOTE: *No concurrent colony-stimulating factors to maintain these values

NOTE: **For patients with liver metastases, AST or ALT ≤ 5 times ULN AND AP normal

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Have received 0-1 prior systemic therapy regimens (prior adjuvant chemotherapy will be considered a prior systemic therapy regimen)
  • At least 4 weeks since prior systemic anticancer therapy (6 weeks for mitomycin C and nitrosoureas)
  • At least 2 weeks since prior radiotherapy and recovered from the side effects to ≤ grade 1
  • At least 2 weeks since prior pleurodesis
  • No concurrent radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alimta and Taxotere
Alimta and Taxotere given in combination with dose modifications.
Taxotere is a third generation cytotoxic chemotherapy agent which is a semisynthetic taxane that inhibits cell division by promoting the rate of microtubule assembly and preventing microtubule depolymerization. It has broad antitumor activity in a range of solid tumors, and has been studied on a weekly as well as a biweekly dosing schedule.
Other Names:
  • Docetaxel
ALIMTA is a novel antifolate drug with three enzyme targets in the purine and pyrimidine synthetic pathway. It has broad activity in solid tumors and has been combined with a number of other chemotherapy agents. Its toxicity is modified by the use of continuous vitamin supplementation.
Other Names:
  • Pemetrexed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum-tolerated dose (MTD) of combination ALIMTA and Taxotere
Time Frame: From first dose of the study drug until 30 days after the last administration of study medication
From first dose of the study drug until 30 days after the last administration of study medication

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: From first dose of the study drug until 30 days after the last administration of study medication
From first dose of the study drug until 30 days after the last administration of study medication
Antitumor activity
Time Frame: From first dose of the study drug until 30 days after the last administration of study medication
From first dose of the study drug until 30 days after the last administration of study medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lee Cranmer, MD, PhD, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 28, 2010

First Submitted That Met QC Criteria

July 28, 2010

First Posted (Estimate)

July 29, 2010

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 05-0108-04
  • P30CA023074 (U.S. NIH Grant/Contract)
  • UARIZ-05-0108-01 (Other Identifier: University of Arizona)
  • UARIZ-HSC0529 (Other Identifier: University of Arizona)
  • UARIZ-SRC17855 (Other Identifier: University of Arizona)
  • LILLY-UARIZ-05-0108-01 (Other Identifier: University of Arizona)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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