Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.

Detailed Description
-----------------
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings. Secondary objectives include: To compare response rate of patients in both treatment arms To compare overall survival of patients in both treatment arms To compare toxicity in both treatment arms To determine whether the survival benefit from suramin is associated with reduced M-phase entry in peripheral blood lymphocytes

Official Title
-----------------
Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Conditions
-----------------
Carcinoma, Non Small Cell Lung

Intervention / Treatment
-----------------
* Drug: Docetaxel
* Drug: Suramin
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically proven diagnosis of non-small cell lung cancer Documented disease progression after first-line chemotherapy for non-small cell lung cancer Stable and treated CNS metastasis is allowed Radiation must be completed at least 2 weeks prior to starting protocol treatment Major surgery must be completed at least 4 weeks prior to starting protocol treatment ECOG performance status 0-2 Sexually active patients must use adequate contraception Adequate bone marrow function Adequate renal function Adequate liver function Exclusion Criteria: Severe hypersensitivity reaction to docetaxel Pre-existing grade 3 or 4 neuropathy Women who are pregnant or breastfeeding Uncontrolled intercurrent illness Receipt of 3 or more prior chemotherapy regimens

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Docetaxel<br> | Drug: Docetaxel<br>* IV over 60 minutes, 75 mg/m2<br>* Other names: Taxotere;|
| Experimental: Docetaxel plus Suramin<br> | Drug: Suramin<br>* IV over 30 minutes<br>Drug: Docetaxel<br>* IV over 60 minutes. 56 mg/m2<br>* Other names: Taxotere;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival in Months | Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate Per RECIST 1.1 Criteria | Response rate per RECIST 1.1, as follows: Complete response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis Partial response (PR): At least 30% decrease in the sum of longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters Progressive disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. (Two lesions increasing from 2mm to 3mm, for example, does not qualify). Stable disease (SD): Neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for PD | Up to 1 year | 
| Overall Survival | Compare overall survival of participants in both treatment arms. | Up to 50 months | 
| Number of Participants With Toxicity/Adverse Events From Treatment | The investigators will compare the toxicity profiles of the two arms of therapy to determine if the docetaxel + suramin has a more favorable toxicity profile than docetaxel alone. This count includes only adverse events considered definitely, probably, or possibly due to treatment. | Up to 2 years | 
| Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control. | The investigators hypothesize that suramin in combination with docetaxel improves response rates and survival by increasing the cancer cell population in the M phase of the cell cycle. The G2-M checkpoint control score, defined as (%M-phase arrested cells after cisplatin+suramin)/(%M-phase arrested cells after cisplatin), is an indicator of the effect of suramin on cell accumulation in the M-phase. G2-M checkpoint control was evaluated as a predictor of PFS and OS in participant receiving suramin by linear correlation. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carcinoma, non small cell lung, Second line, Third line