Pemetrexed Disodium and Docetaxel in Treating Patients With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2014-07-31

Brief Summary

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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

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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

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Breast Cancer Esophageal Cancer Gastric Cancer Head and Neck Cancer Lung Cancer Ovarian Cancer Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alimta and Taxotere

Alimta and Taxotere given in combination with dose modifications.

Group Type EXPERIMENTAL

Taxotere (Docetaxel)

Intervention Type 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.

Alimta (Pemetrexed)

Intervention Type 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.

Interventions

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Taxotere (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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Docetaxel Pemetrexed

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lee Cranmer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Site Status

Countries

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United States