Exemestane, Pemetrexed Disodium, and Carboplatin in Treating Post-Menopausal Women With Stage IV Non-Small Cell Lung Cancer

NCT01664754 | Completed Phase 1 DMC

• 2 other identifiers: 11-003323NCI-2012-01250
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best dose of exemestane in combination with pemetrexed disodium and carboplatin in treating post-menopausal women with stage IV non-small cell lung cancer. Exemestane may stop the growth of tumor calls by blocking some of the enzymes need for cell growth. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving exemestane together with pemetrexed disodium and carboplatin may kill more tumor cells

Conditions

Stage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Tabulation, grading, and attribution of serious adverse events (SAEs) and adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

  Up to 3 years

Secondary Outcomes (2)

• Proportion achieving clinical response

  Up to 3 years

• Quality of life in patients treated with pemetrexed disodium, carboplatin and exemestane

  Up to 3 years

Study Arms (1)

Treatment (exemestane, pemetrexed disodium, and carboplatin)

EXPERIMENTAL

Patients receive exemestane PO QD on days 1-28 and pemetrexed disodium IV over 15 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: exemestane; Drug: pemetrexed disodium; Drug: carboplatin; Other: laboratory biomarker analysis; Other: pharmacological study; Other: questionnaire administration; Procedure: quality-of-life assessment

Interventions

exemestane DRUG

Given PO

Also known as: Aromasin, FCE-24304, PNU 155971

Treatment (exemestane, pemetrexed disodium, and carboplatin)

pemetrexed disodium DRUG

Given IV

Also known as: ALIMTA, LY231514, MTA

Treatment (exemestane, pemetrexed disodium, and carboplatin)

carboplatin DRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Treatment (exemestane, pemetrexed disodium, and carboplatin)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (exemestane, pemetrexed disodium, and carboplatin)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (exemestane, pemetrexed disodium, and carboplatin)

questionnaire administration OTHER

Ancillary studies

Treatment (exemestane, pemetrexed disodium, and carboplatin)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Treatment (exemestane, pemetrexed disodium, and carboplatin)

Eligibility Criteria

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

You may qualify if:

• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI)
• Histologically or cytologically confirmed, treatment-naive (or status post a single treatment regimen of a tyrosine kinase inhibitor as a single agent) stage IV non-squamous, NSCLC
• Measurable disease according to modified RECIST version 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
• Expected survival time of \>= 3 months in the opinion of the investigator
• Postmenopausal women; women are eligible if they are postmenopausal (older than 50 years of age with no spontaneous menses for at least 12 months; or 50 years of age or younger either with no spontaneous menses \[amenorrheic\] within 12 months of randomization \[e.g., spontaneous or secondary to hysterectomy\] and a follicle-stimulating hormone level within the postmenopausal range or with prior bilateral oophorectomy)
• Ability to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample containing representative tumor tissue from a previously obtained biopsy/resection that meets specific tissue sample requirements at screening

You may not qualify if:

• History of another primary cancer within 3 years prior to day 1 with the exception of curatively treated skin cancer (other than melanoma) or curatively treated cervical carcinoma in-situ
• Untreated central nervous system (CNS) involvement; (treated CNS involvement is permitted only if the patient is not currently on steroid therapy or has remained on a stable, unchanged dose of steroid for \>= 3 weeks)
• Recent major surgery within the prior 4 weeks; (mediastinoscopy or placement of a central venous access will be allowed as long as placement was more than 7 days prior to receiving study drug)
• Any prior or concurrent investigational or standard therapy for treatment of metastatic NSCLC including radiation therapy, chemotherapy, biological therapy (with the exception of a single treatment regimen of a tyrosine kinase inhibitor as a single agent, which must be completed 28 days prior to day 1), hormonal therapy, or immunotherapy; (palliative-targeted radiotherapy for brain or bone metastases is permitted providing it has been at least 14 days prior to day 1)
• History of hormone replacement therapy (estrogens with or without progestin) or an aromatase inhibitor (anastrazole, letrozole, exemestane) within 8 weeks prior to day 1
• Osteoporosis complicated by pathologic fracture
• Concurrent investigational agents for non-malignant disease or prior investigational agents for non-malignant disease within 4 weeks or 5 half-lives (whichever is shorter) prior to day 1
• Concurrent cytotoxic or immunosuppressive therapy for non-malignant disease (e.g., for rheumatoid arthritis or lupus)
• Absolute neutrophil count (ANC) \< 1500/mL
• Platelet count \< 100,000/mL
• Hemoglobin \< 9.0 g/dL
• Serum bilirubin \> 1.5 x upper limits of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2.5 x ULN (AST and ALT \> 5 x ULN for subjects with liver metastasis)
• Glomerular filtration rate (GFR) =\< 50
• Albumin =\< 2.5 g/dL

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

exemestane; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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; Coordination Complexes; Organic Chemicals

Study Officials

• Edward Garon

  Jonsson Comprehensive Cancer Center

  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: August 10, 2012
• First Posted: August 14, 2012
• Study Start: September 7, 2012
• Primary Completion: January 11, 2019
• Study Completion: January 11, 2019
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

US (1)