Clinical trial NCT02120807: Certolizumab in Combination With Chemotherapy for Patients With Stage IV Lung Adenocarcinomas
Official title: A Phase I Trial of Certolizumab in Combination With Chemotherapy for Patients With Stage IV Lung Adenocarcinomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stage IV Lung Adenocarcinoma
Keywords: Certolizumab
Cisplatin
Pemetrexed
thoracic
13-063
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-04-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety of certolizumab when it is given with the chemotherapy drugs cisplatin and pemetrexed. Cisplatin and pemetrexed are two chemotherapy drugs used in the treatment of lung cancer. The investigators want to find out what effects, good and/or bad, certolizumab has on the patient and lung cancer.


Eligibility criteria: Inclusion Criteria:

* Previously untreated stage IV lung adenocarcinoma confirmed at MSKCC
* Age 18 years or older
* Karnofsky Performance Status ≥ 70
* Patients with locally treated, stable, and/or asymptomatic brain metastases are eligible.
* Adequate bone marrow, liver and renal function, as specified below:
* Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
* Hemoglobin ≥ 8 g/dL
* Platelets ≥ 100 x 109/L
* Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's Syndrome)
* AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present
* Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal.
* Negative PPD test
* For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
* Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter
* Presence of at least one site of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors
* Archival tissue (10 Unstained Slides - 5 micron sections) from a core biopsy performed and received within 30 days before signing consent or ability to have a fresh core biopsy performed
* Biopsy cannot be from any cytology or bone specimen
* Biopsy site must be amenable to re-biopsy at the end of the study
* Ability to provide written, informed consent

Exclusion Criteria:

* Hypersensitivity to platinum agents
* Ongoing use of investigational agents or use of investigational agents within the last four weeks
* Prior use of agents for TNF-alpha blockade
* History of rheumatoid arthritis, inflammatory bowel disease, or psoriatic arthritis
* Baseline hearing deficit (CTCAE version 4.0 grade 2 or higher)
* Ongoing bacterial, viral, or antifungal infection requiring antimicrobial treatment with the exception of thrush
* Active tuberculosis or untreated, latent tuberculosis

  o If a patient has signs, symptoms, or a history suggestive of active tuberculosis, evaluation by an infectious disease physician will be required and active tuberculosis ruled-out prior to enrollment.
* Acute or chronic Hepatitis B or C infection
* Known HIV infection requiring antiretroviral medications and those with AIDS
* Active herpes zoster infection
* Non-healed infected skin ulcers
* History of myocardial infarction or unstable angina within the past 12 months
* Ongoing use of other immunosuppressive medications, including oral steroids and excluding topical steroids
* Women who are breastfeeding Prior history of other malignancy with the exclusion of localized prostate cancer, non-melanomatous skin cancer, ductal carcinoma or lobular carcinoma in situ of the breast

Primary outcomes:
measure: Maximum tolerated does (MTD)
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 2 years
measure: Immunohistochemical staining
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Paul Paik
role: PRINCIPAL_INVESTIGATOR
References: