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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Lung Cancer, Ovarian Cancer, Prostate Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum-tolerated dose (MTD) of combination ALIMTA and Taxotere

Outcome Time Frame:

From first dose of the study drug until 30 days after the last administration of study medication

Safety Issue:

Yes

Principal Investigator

Lee Cranmer, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona

Authority:

United States: Food and Drug Administration

Study ID:

05-0108-04

NCT ID:

NCT01172028

Start Date:

September 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Ovarian Cancer
  • Prostate Cancer
  • 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
  • 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
  • Breast Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Ovarian Neoplasms
  • Prostatic Neoplasms

Name

Location

Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724