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CompletedPhase 1NCT01172028
Official study title

Pemetrexed Disodium and Docetaxel in Treating Patients With Advanced Solid Tumors

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTaxotere (Docetaxel) and Alimta (Pemetrexed)

The study team can explain what participation involves.

Who it may be forBreast Cancer · Esophageal Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 3, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Arizona

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
University of Arizona
Interventions being studied
Drug: Taxotere (Docetaxel); Drug: Alimta (Pemetrexed)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 3, 2015. Always confirm current availability with the study team.

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