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

Non-small Cell Lung Cancer Clinical Trial

Official title:

Combination of Non-Cytotoxic Suramin With Docetaxel and Carboplatin in Chemo-Naive Non-small Cell Lung Cancer (NSCLC): A Randomized Single-Blind Placebo-Controlled Phase II Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01038752
• Other study ID #: Optimum-Suramin-1
• Status: Terminated
• Phase: Phase 2
• First received: December 22, 2009
• Last updated: May 4, 2015
• Start date: August 2010
• Est. completion date: May 2013

Study information

• Verified date: May 2015
• Source: Optimum Therapeutics, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Suramin Drug:Docetaxel Drug: Carboplatin
Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour).
• Placebo Drug: Docetaxel Drug: Carboplatin
Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour).

Locations

Country	Name	City	State
United States	John H Stroger Jr Hospital of Cook County	Chicago	Illinois
United States	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Optimum Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria	Insufficient data	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.	No
Secondary	Overall Survival of Participants	Insufficient Data	First treatment date to date of death	No
Secondary	Overall Response Rate (Complete Response + Partial Response) of Participants	Insufficient data	Tumor assessment at every other cycle	No
Secondary	Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin.	Insufficient data.	Day 1 of each cycle; end of treatment visit; at follow-up.	Yes
Secondary	Pre-treatment bFGF Levels Correlation With Survival.	Insufficient data.	Before first treatment	No
Secondary	Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes	Insufficient data.	Randomization date	No
Secondary	To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients.	Insufficient data.	Randomization date to date of death	No
Secondary	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.	Insufficient data.	Randomization date to date of death	No