Evaluation of Non-cytotoxic Suramin as a Chemosensitizer in Non-small Cell Lung Cancer

Phase 2

Terminated

Conditions: Non-small Cell Lung Cancer

Registration Number: NCT01038752

Lead Sponsor: Optimum Therapeutics, LLC

Brief Summary: The purpose of this study is to evaluate the benefit of adding suramin at a non-cytotoxic dose to carboplatin and docetaxel regimen in the treatment of chemo-naïve patients with non-small cell lung cancer.

Detailed Description: The primary objective is to determine the progression free survival for patients with stage III B with malignant pleural effusion or Stage IV NSCLC treated with docetaxel and carboplatin with or without suramin.

The secondary objectives are to compare median overall survival rate, compare overall response rate of patients in both arms, assess toxicity of suramin with docetaxel and carboplatin, determine whether pre-treatment bFGF levels correlate with survival, to determine whether survival benefit from suramin is associated with M phase entry in peripheral blood lymphocytes, and to determine whether adding suramin to docetaxel and carboplatin produces greater survival benefits in African-American patients.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 14

Inclusion Criteria

Histologically or cytologically proven on-small cell lung cancer (NSCLC), including squamous cell carcinoma.
Newly-diagnosed stage IIIB with malignant pleural effusion, stage IV or recurrent disease.
Known central nervous system metastases if patients are asymptomatic and have completed whole brain or stereotactic radiation at least 2 weeks prior or surgery at least 4 weeks prior to starting treatment on this protocol. Must be off dexamethasone at the time of starting treatment.
Must have completed radiotherapy at least two weeks prior to registration. Prior radiation therapy is eligible if patient has a measurable lesion that has not been irradiated.
Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (RECIST criteria).
Lesions that are not considered measurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions situated in a previously irradiated area
ECOG performance status of 0-1.
Life expectancy ≥ 3 months.
Adequate bone marrow function, absolute neutrophil count ≥1,500/mm3, hemoglobin ≥9.9 gm/dl, and platelet count ≥100,000/mm3.
Adequate liver function defined as bilirubin ≤ 1x upper level of the institutional normal (ULIN). AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. See protocol.
Must have adequate renal function defined as serum creatinine ≤ 2.0 mg/dl or calculated creatinine clearance ≥ 60 ml/min for patients with creatinine levels above 2.0 mg/dl.
Must have recovered from uncontrolled intercurrent illness, including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
Use of adequate contraception (hormonal or barrier method of birth control) for the duration of study participation and continued for at least three months after completing treatment. Non-pregnant status will be determined in all women of childbearing potential.
Age > 18.
Patients must have given written informed consent.
Entry to this study is open to both men and women and to all racial and ethnic subgroups. The goal is to accrue a minimum of 44 patients of African-American ancestry and a maximum of 120 non-African-American patients. Classification of patient race and ancestry will be based on patient's self-identification on the consent form for the clinical trial.

Exclusion Criteria

History of severe hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate 80.
Grade 3 or 4 neuropathy.
Women who are pregnant or breast-feeding.
Prior chemotherapy or biologic therapy (e.g., erlotinib) for NSCLC including neoadjuvant or adjuvant chemotherapy.
Currently active second malignancy other than non-melanoma skin cancer. Currently active malignancy does not include prior malignancy treated with therapy and considered to have less than 30% risk of relapse.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria	Patients will be followed every 2 months for the first 6 months following the last cycle of treatment, every three months for the next year, and every 6 months thereafter.	Insufficient data

Secondary Outcome Measures

Name	Time	Method
Overall Survival of Participants	First treatment date to date of death	Insufficient Data
Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes	Randomization date	Insufficient data.
Overall Response Rate (Complete Response + Partial Response) of Participants	Tumor assessment at every other cycle	Insufficient data
Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin.	Day 1 of each cycle; end of treatment visit; at follow-up.	Insufficient data.
Pre-treatment bFGF Levels Correlation With Survival.	Before first treatment	Insufficient data.
To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients.	Randomization date to date of death	Insufficient data.
To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Greater Survival Benefits in African-American Patients Compared to Non-African-American Patients.	Randomization date to date of death	Insufficient data.

Trial Locations

Locations (2): John H Stroger Jr Hospital of Cook County
🇺🇸
Chicago, Illinois, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸
Richmond, Virginia, United States
John H Stroger Jr Hospital of Cook County
🇺🇸Chicago, Illinois, United States