Evaluation of Non-cytotoxic Suramin as a Chemosensitizer in Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Suramin Drug:Docetaxel Drug: Carboplatin; Placebo Drug: Docetaxel Drug: Carboplatin
Intervention description: 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 (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).
Intervention MeSH terms: Suramin; Carboplatin; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC; suramin; lung cancer; chemotherapy

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.
    

Eligibility criteria:

        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.