Gene Expression Levels in Predicting Treatment Response in Patients With Stage IV Non-small Cell Lung Cancer

NCT02145078 | Terminated Results DMC

• 4 other identifiers: 2013-177NCI-2014-010231402012854P30CA022453
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies whether the levels of certain genes in the tissue and blood are related to how well patients with stage IV non-small cell lung cancer respond to chemotherapy. Genes may affect how sensitive or resistant tumors are to chemotherapy. Studying the levels of genes related to tumor response before and after chemotherapy may help doctors learn whether they can predict how well patients will respond to treatment.

Conditions

Recurrent Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Baseline Marker Measurement

  A univariable regression of continuous disease response on baseline marker value will be performed. A multivariable regression model adjusted for clinical covariates will be evaluated as well. Expression levels of RRM1, TS, BRCA1, and other molecules and disease response after course 2 will be log-transformed.

  Baseline

Secondary Outcomes (4)

• Change in Biomarker Expression Levels

  Baseline to up to 8 weeks (after course 2)

• Overall Survival (OS)

  From the date of protocol-specified treatment initiation to the date of death or last observation, assessed up to 12 months

• Progression-free Survival (PFS)

  From the date of protocol-specified treatment initiation to the date of progression, death, or last observation, assessed up to 12 months

• Expression Levels of Biomarkers and Other Molecules

  Up to 8 weeks (end of course 2)

Study Arms (1)

Treatment (chemotherapy regimen)

EXPERIMENTAL

Patients receive 1 of 4 chemotherapy regimens at the discretion of the primary oncologist following institutional guidelines, including cisplatin, carboplatin, pemetrexed disodium IV on day 1, or gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After course 2, patients may continue treatment off-study at the discretion of the treating physician.

Drug: docetaxel; Drug: pemetrexed disodium; Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis

Interventions

docetaxel DRUG

Given IV

Also known as: RP 56976, Taxotere, TXT

Treatment (chemotherapy regimen)

pemetrexed disodium DRUG

Given IV

Also known as: ALIMTA, LY231514, MTA

Treatment (chemotherapy regimen)

gemcitabine hydrochloride DRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Treatment (chemotherapy regimen)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (chemotherapy regimen)

Eligibility Criteria

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

You may qualify if:

• Patients with advanced stage NSCLC who are candidates for single or multi-agent first-line therapy.
• Second-line or higher therapy for any patients with NSCLC with performance status (PS) 0-2
• Maintenance therapy for patients after completion of four cycles of dual-agent platinum-based chemotherapy
• Stage IV, histologically or cytologically confirmed NSCLC; confirmation may be obtained with the first protocol-specified tumor biopsy
• White blood cell count \> 3000/mm\^3
• Platelet count \> 100,000/mm\^3
• Hemoglobin \> 9.0 g/dl
• A tumor lesion that can be safely biopsied as judged by the treating oncologist and physician performing the procedure and has not been radiated
• At least one unidimensionally measurable tumor lesion \>= 1 cm in longest diameter using spiral CT (\>= 2 cm in longest diameter by any other technique) that has not been radiated and is not located in a bone
• Performance status 0-2 by Eastern Cooperative Oncology Group criteria
• Life expectancy of \>= 3 months
• Able to understand and sign the informed consent document

You may not qualify if:

• Therapy that does not include cisplatin, carboplatin, gemcitabine, and/or pemetrexed
• Concomitant medical or psychiatric illness that is likely to interfere with a reasonably safe execution of the treatment plan
• Concomitant malignancy other than NSCLC that requires active therapy; prior malignancies are allowed as long as the disease is controlled and does not require ongoing therapy of any kind; prior therapy must have concluded at least 1 year before treatment initiation on this protocol; exceptions are non-melanoma skin cancer, prostate cancer and prostatic intraepithelial neoplasia (PIN) treated with local intervention and deemed cured, cervical cancer and carcinoma in situ (CIS) treated with local intervention and deemed cured, and laryngeal cancer and CIS treated with local intervention and deemed cured
• Carcinomatous meningitis
• Uncontrolled central nervous system (CNS) disease
• The time interval between CNS radiation, whole brain radiation, spinal cord radiation, or radiosurgery, and initiation of protocol specified chemotherapy must be at least 1 week
• Malignant pleural, pericardial, or peritoneal effusion if it is the only site of disease activity; i.e., if no other measurable tumor lesions exist
• Coagulopathy or anticoagulation therapy that cannot be safely corrected or interrupted for tumor biopsy
• Significant hepatic dysfunction, renal dysfunction, or metabolic derangement that precludes full-dose chemotherapy at the specified starting doses
• Concomitant treatment with chemotherapeutic agents for diseases other than malignancy
• Pregnancy or lactation

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Pemetrexed; Gemcitabine

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)

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

This study was stopped because of low accrual.

Results Point of Contact

• Title: Gerold Bepler
• Organization: Barbara Ann Karmanos Cancer Institute

beplerg@karmanos.org

(313)576-8670

Study Officials

• Gerold Bepler

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 22, 2014
• Study Start: June 1, 2014
• Primary Completion: June 18, 2015
• Study Completion: March 7, 2017
• Last Updated: September 24, 2020
• Results First Posted: September 24, 2020

Record last verified: 2020-09

Locations

US (1)