NCT00215930

The 'MADe IT' Clinical Trial: Molecular Analyses Directed Individualized Therapy for Advanced Non-Small Cell Lung Cancer

Phase II Study on the Use of Molecular Analyses-Based Customized Chemotherapy in Patients With Stage IV/IIIB (Malignant Pleural Effusion) Non-Small-Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The standard treatment for non-small cell lung cancer, stage IV or IIIB malignant pleural effusion is chemotherapy. The decision to use a regimen is currently determined by toxicity or by physician's preference. In this protocol, the treatment regimen will be assigned based on the patients' tumor molecular profile. A tumor molecular profile analysis will allow the physician to define a specific molecular portrait that shows the genetic basis of the tumor. This analysis results in a detailed report that will determine which chemotherapy will be assigned to the patient.

Detailed description

Evaluation at study entry will include blood tests, computerized tomography (CT) scans or other types of scans needed to measure other disease sites. A biopsy of one tumor is required for tumor analysis. If the patient's cancer has spread to other locations that may be easier to obtain tissue from and be less invasive, then the biopsy specimen may be collected from one of several possible locations that may exist within the patient's body. These possible sites include lung, bone, liver, adrenal glands, lymph nodes, nodules under the skin, or in cases of brain involvement requiring surgery, brain tissue. Sometimes fluids build up between the lining of the lung and the lung itself. If this happened to the patient and their doctor tells them the fluid should be drained, then this fluid may also be a source of cells we can use to analyze the patients cancer. In very rare cases, other sites might be identified. Chemotherapy will consist of the assigned two drugs. Chemotherapy will be repeated every three or four weeks for at least two times. Patients will then have a CT scan to measure their tumor's response. Response can be reduction of tumor size, no change of tumor size, or increased tumor size. Doing CT Scans or other tests after every two cycles of chemotherapy will assess for response. If we see a favorable response we will continue chemotherapy for a maximum of two times after the best response we can see in the patient's tumor. If the patient's tumor grows larger, then we discontinue the study and the patient will discuss other treatment options with their doctor. During treatment, a blood specimen will be obtained to check the patient's blood counts at the beginning and end of study, and prior to administration of every dose of chemotherapy. Approximately 3 teaspoonfuls (15 mls) of blood will be drawn each time.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Vinorelbine	Ribonucleotide reductase subunit 1(RRM1)above 16.5 and Excision repair cross-complementing group 1 gene(ERCC1)above 8.7: Treat patients with Docetaxel and Vinorelbine (DV). DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days.
DRUG	Docetaxel	RRM1 below 16.5 and ERCC1 above 8.7: Treat patients with Gemcitabine and Docetaxel (GD). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days. RRM1 above 16.5 and ERCC1 below 8.7: Treat patients with Docetaxel and Carboplatin (DC). DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days. RRM1 above 16.5 and ERCC1 above 8.7: Treat patients with Docetaxel and Vinorelbine (DV). DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days.
DRUG	Gemcitabine	Ribonucleotide reductase subunit 1(RRM1) below 16.5, and Excision repair cross-complementing group 1 gene(ERCC1) below 8.7: Patients treated with Gemcitabine and Carboplatin (GC). GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve \[AUC\] of 5 on day 1) every 21 days. RRM1 below 16.5 and ERCC1 above 8.7: Treat patients with Gemcitabine and Docetaxel (GD). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days.
DRUG	Carboplatin	Ribonucleotide reductase subunit 1(RRM1) below 16.5, and Excision repair cross-complementing group 1 gene(ERCC1) below 8.7: Patients treated with Gemcitabine and Carboplatin (GC). GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve \[AUC\] of 5 on day 1) every 21 days. RRM1 above 16.5 and ERCC1 below 8.7: Treat patients with Docetaxel and Carboplatin (DC). DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days.

Timeline

• Start date: 2004-02-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2005-09-22
• Last updated: 2017-03-23
• Results posted: 2011-02-23

Locations

1 site across 1 country: United States