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

Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

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

Inclusion Criteria:

- Histologically or cytologically proven NSCLC, including squamous cell carcinoma.

- Newly-diagnosed stage IIIB with malignant pleural effusion, stage IV or recurrent

- Known CNS 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the progression free survival for patients with stage IIIB/IV NSCLC treated with docetaxel and carboplatin with or without suramin.

Outcome Time Frame:

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.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

July 2017

Related Keywords:

  • Non-Small Cell Lung Cancer
  • suramin
  • lung cancer
  • chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
John H Stroger Jr Hospital of Cook CountyChicago, Illinois  60612-3785