Pemetrexed Disodium and Docetaxel in Treating Patients With Advanced Solid Tumors

NCT01172028 | Completed Phase 1 DMC

• 6 other identifiers: 05-0108-04P30CA023074UARIZ-05-0108-01UARIZ-HSC0529UARIZ-SRC17855LILLY-UARIZ-05-0108-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

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; 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

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• 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

Study Arms (1)

Alimta and Taxotere

EXPERIMENTAL

Alimta and Taxotere given in combination with dose modifications.

Drug: Taxotere (Docetaxel); Drug: Alimta (Pemetrexed)

Interventions

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.

Also known as: Docetaxel

Alimta and Taxotere

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.

Also known as: Pemetrexed

Alimta and Taxotere

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5024, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Head and Neck Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms, Male; Esthesioneuroblastoma, Olfactory; Salivary Gland Neoplasms; Carcinoma, Ovarian Epithelial; Hypopharyngeal Neoplasms; Laryngeal Neoplasms

Interventions

Docetaxel; Pemetrexed

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroblastoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Olfactory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Carcinoma; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Lee Cranmer, MD, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: July 29, 2010
• Study Start: September 1, 2005
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 3, 2015

Record last verified: 2014-02

Locations

US (1)