Clinical trial NCT01356368: Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer
Official title: A Pilot Study of Customizing First Line Chemotherapy in Advanced Non-Small Cell Lung Cancer Based on Molecular Markers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Lung cancer
Lead sponsor: National Guard Health Affairs
Sponsor class: OTHER_GOV
First posted: 2011-05-19
Enrollment: 3
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 study aims at piloting the concept of customization of chemotherapy based on molecular markers in patients with stage IIIB (with pleural effusion) and IV with performance status ≤ 2 with pathologically proven non-small cell lung cancer (NSCLC). The study will not test or compare individual regimen but rather it will test the approach of customization concept as a whole.

The results of this pilot study will help in designing more definitive trials in our patient population.

Detailed description: The treatment of advanced NSCLC cancer includes various chemotherapies with equivalent regimens that have reached a therapeutic plateau. The selection of these regimens is completely empirical and physician dependent. Potential predictors of specific agent efficacy exist in the form of tumor molecular markers that are a reflection of the individual's genetic make up. Thus our study aims at utilizing these markers to more efficiently select the regimen in order to maximize the benefit to the patients rather than using empiric approaches. Fortunately, each of our selected regimens contains active and well-studied agents in the treatment of lung cancer (Table 1). This pilot study will help us determine the benefit, and safety of this approach (not individual regimen). The study is not to compare individual regimens but it aims at testing the whole concept of customization of chemotherapy based on molecular markers to help us in the future at selecting regimens based on these markers and not empirically. The results then will be used to determine more definitive future studies.

Furthermore, circulating tumor cells in the blood represent the future distant metastases that result in disease progression to incurable stages. The circulating tumor cells have the ability to cross into vessels, travel in circulation, and exit the vessels into tissues where they have the capability to grow. Therefore, these cells may express different biological and molecular features from the stationary cells in the primary tumors. Therefore, exploiting these circulating tumor cells for augmenting treatment approaches is of vital importance and utility.

Eligibility criteria: Inclusion Criteria:

1. Microscopic diagnosis of NSCLC stages IIIB (with malignant pleural effusion) and IV
2. Having adequate tissue sample to perform the markers testing
3. Age ≥ 18 years
4. No prior chemotherapy treatment for lung cancer (Surgery and radiotherapy are acceptable)
5. No other concurrent cancer treatment
6. Performance status of 0- 2 per ECOG scale (Appendix II)
7. Adequate laboratory values as follows as follows:

   Absolute neutrophil count ≥ 1500/mm3 Platelet count ≥100, 000/ mm3 Total bilirubin ≤ 1.25X institutional upper normal level AST and ALT ≤ 3 X institutional upper normal level Serum creatinine ≤ 1.5 X institutional upper normal level
8. Presence of measurable disease

Exclusion Criteria:

1. Prior systemic treatment for lung cancer
2. History of hypersensitivity to drugs used
3. Diagnosis of other malignancy in the last 5 years excluding curatively treated non-melanoma skin cancer and in-situ cervical cancer
4. Medical illness that puts the patient at significant risk per investigator's discretion
5. Uncontrolled CNS disease. Patients with CNS metastatic disease treated with radiotherapy or surgery will be eligible if the CNS disease is stable 4 weeks after the treatment initiation without increase dose of steroids
6. Positive pregnancy test or refusal to use contraception during treatment. (Gynecology consultant for contraception)

Primary outcomes:
measure: Efficacy and Safety
timeFrame: 3 years
Secondary outcomes:
measure: Tumor marker
timeFrame: 3 years
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdul Aziz Medical City for National Guard Health Affairs
Study officials:
affiliation: King Abdul Aziz Medical City for National Guard
name: Abdulrahman Jazieh, MD/MPH
role: PRINCIPAL_INVESTIGATOR
References: