Pemetrexed Disodium and Docetaxel in Treating Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT01172028
First received: July 28, 2010
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Esophageal Cancer
Gastric Cancer
Head and Neck Cancer
Lung Cancer
Ovarian Cancer
Prostate Cancer
Drug: Texotere (Docetaxel)
Drug: Alimta (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 Dose Escalation Trial of Biweekly Alimta (With Vitamin Supplementation) in Combination With Taxotere in Advanced Solid Tumor Patients

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: From first dose of the study drug until 30 days after the last administration of study medication ] [ Designated as safety issue: Yes ]
  • Antitumor activity [ Time Frame: From first dose of the study drug until 30 days after the last administration of study medication ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: September 2005
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alimta/Taxotere Drug: Texotere (Docetaxel)
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.
Drug: Alimta (Pemetrexed)
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.

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.

  Eligibility

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

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
  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: NCT01172028

Locations
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Lee Cranmer, MD, PhD University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01172028     History of Changes
Other Study ID Numbers: 05-0108-04, P30CA023074, UARIZ-05-0108-01, UARIZ-HSC0529, UARIZ-SRC17855, LILLY-UARIZ-05-0108-01
Study First Received: July 28, 2010
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arizona:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
male breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent breast cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer
stage III esophageal cancer
stage IV esophageal cancer
recurrent esophageal cancer
recurrent adenoid cystic carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
recurrent basal cell carcinoma of the lip
stage III basal cell carcinoma of the lip
stage IV basal cell carcinoma of the lip
recurrent lymphoepithelioma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
recurrent lymphoepithelioma of the oropharynx
stage III lymphoepithelioma of the oropharynx

Additional relevant MeSH terms:
Breast Neoplasms
Esophageal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Stomach Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Genital Neoplasms, Male

ClinicalTrials.gov processed this record on August 28, 2014