Pemetrexed Disodium and Docetaxel in Treating Patients With Advanced Solid Tumors
Official Title
Phase I Dose Escalation Trial of Biweekly Alimta (With Vitamin Supplementation) in Combination With Taxotere in Advanced Solid Tumor Patients
Acronym
Not provided
Organization
University of ArizonaOTHER
Status Module
Record Verification Date
Feb 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2005
Primary Completion Date
Jul 2014Actual
Completion Date
Jul 2014Actual
First Submitted Date
Jul 28, 2010
First Submission Date that Met QC Criteria
Jul 28, 2010
First Posted Date
Jul 29, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 2, 2015
Last Update Posted Date
Dec 3, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
University of ArizonaOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
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.
Conditions Module
Conditions
Breast Cancer
Esophageal Cancer
Gastric Cancer
Head and Neck Cancer
Lung Cancer
Ovarian Cancer
Prostate Cancer
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
33Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Alimta and Taxotere
Experimental
Alimta and Taxotere given in combination with dose modifications.
Drug: Taxotere (Docetaxel)
Drug: Alimta (Pemetrexed)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Taxotere (Docetaxel)
Drug
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum-tolerated dose (MTD) of combination ALIMTA and Taxotere
From first dose of the study drug until 30 days after the last administration of study medication
Secondary Outcomes
Measure
Description
Time Frame
Toxicity
From first dose of the study drug until 30 days after the last administration of study medication
Antitumor activity
From first dose of the study drug until 30 days after the last administration of study medication
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Lee Cranmer, MD, PhD
University of Arizona
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson
Arizona
85724-5024
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D001943
Breast Neoplasms
D004938
Esophageal Neoplasms
D013274
Stomach Neoplasms
D006258
Head and Neck Neoplasms
D008175
Lung Neoplasms
D010051
Ovarian Neoplasms
D011471
Prostatic Neoplasms
D002289
Carcinoma, Non-Small-Cell Lung
D018567
Breast Neoplasms, Male
D018304
Esthesioneuroblastoma, Olfactory
D012468
Salivary Gland Neoplasms
D000077216
Carcinoma, Ovarian Epithelial
D007012
Hypopharyngeal Neoplasms
D007822
Laryngeal Neoplasms
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D009369
Neoplasms
D001941
Breast Diseases
D012871
Skin Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D000077143
Docetaxel
D000068437
Pemetrexed
Ancestor Terms
ID
Term
D043823
Taxoids
D043822
Cyclodecanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
Browse Leaves
Not provided
Browse Branches
Not provided
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
stage IV lymphoepithelioma of the oropharynx
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage III inverted papilloma of the paranasal sinus and nasal cavity
stage III midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
stage III ovarian germ cell tumor
stage IV ovarian germ cell tumor
recurrent ovarian germ cell tumor
stage III gastric cancer
stage IV gastric cancer
recurrent gastric cancer
recurrent hypopharyngeal cancer
stage III hypopharyngeal cancer
stage IV hypopharyngeal cancer
recurrent laryngeal cancer
stage III laryngeal cancer
stage IV laryngeal cancer
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Alimta and Taxotere
Docetaxel
Alimta (Pemetrexed)
Drug
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.
Alimta and Taxotere
Pemetrexed
D017437
Skin and Connective Tissue Diseases
D005770
Gastrointestinal Neoplasms
D004067
Digestive System Neoplasms
D004066
Digestive System Diseases
D004935
Esophageal Diseases
D005767
Gastrointestinal Diseases
D013272
Stomach Diseases
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D004701
Endocrine Gland Neoplasms
D010049
Ovarian Diseases
D000291
Adnexal Diseases
D005831
Genital Diseases, Female
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications