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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01038752
Recruitment Status : Terminated
First Posted : December 24, 2009
Results First Posted : October 21, 2014
Last Update Posted : May 21, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Suramin Drug:Docetaxel Drug: Carboplatin Drug: Placebo Drug: Docetaxel Drug: Carboplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : August 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Suramin
This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.
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).
Other Names:
  • CI-1003
  • PD 002927-0015F
  • NSC 34936
  • Bayer 205
  • Germanin
  • Metaret
  • Taxotere
  • Paraplatin

Placebo Comparator: Standard of care
This group will receive placebo with docetaxel and carboplatin.
Drug: 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).
Other Names:
  • Taxotere
  • Paraplatin

Primary Outcome Measures :
  1. Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria [ 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. ]
    Insufficient data

Secondary Outcome Measures :
  1. Overall Survival of Participants [ Time Frame: First treatment date to date of death ]
    Insufficient Data

  2. Overall Response Rate (Complete Response + Partial Response) of Participants [ Time Frame: Tumor assessment at every other cycle ]
    Insufficient data

  3. Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin. [ Time Frame: Day 1 of each cycle; end of treatment visit; at follow-up. ]
    Insufficient data.

  4. Pre-treatment bFGF Levels Correlation With Survival. [ Time Frame: Before first treatment ]
    Insufficient data.

  5. Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes [ Time Frame: Randomization date ]
    Insufficient data.

  6. To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients. [ Time Frame: Randomization date to date of death ]
    Insufficient data.

  7. 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. [ Time Frame: Randomization date to date of death ]
    Insufficient data.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01038752

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United States, Illinois
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Optimum Therapeutics, LLC

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Responsible Party: Optimum Therapeutics, LLC Identifier: NCT01038752     History of Changes
Other Study ID Numbers: Optimum-Suramin-1
First Posted: December 24, 2009    Key Record Dates
Results First Posted: October 21, 2014
Last Update Posted: May 21, 2015
Last Verified: May 2015

Keywords provided by Optimum Therapeutics, LLC:
lung cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antinematodal Agents
Antiparasitic Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents