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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Optimum Therapeutics, LLC
ClinicalTrials.gov Identifier:
NCT01038752
First received: December 22, 2009
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Drug: Suramin + Docetaxel + Carboplatin
Drug: Placebo + Docetaxel + Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Combination of Non-Cytotoxic Suramin With Docetaxel and Carboplatin in Chemo-Naive NSCLC: A Randomized Single-Blind Placebo-Controlled Phase II Study

Resource links provided by NLM:


Further study details as provided by Optimum Therapeutics, LLC:

Primary Outcome Measures:
  • To determine the progression free survival for patients with stage IIIB/IV NSCLC treated with docetaxel and carboplatin with or without suramin. [ 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare median overall survival of patients with stage IIIB/IV NSCLC in the two treatment arms. [ Time Frame: February 2017 ] [ Designated as safety issue: No ]
  • To compare the overall response rate (complete response + partial response) of patients with stage IIIB/IV NSCLC in the two treatment arms. [ Time Frame: February 2017 ] [ Designated as safety issue: No ]
  • To assess the toxicity of combination of non-cytotoxic suramin with docetaxel and carboplatin. [ Time Frame: Within 30 days of final cycle ] [ Designated as safety issue: Yes ]
  • To determine whether pre-treatment bFGF levels correlate with survival. [ Time Frame: February 2017 ] [ Designated as safety issue: No ]
  • To determine whether the survival benefit from non-cytotoxic suramin is associated with reduced M phase entry in peripheral blood lymphocytes. [ Time Frame: February 2017 ] [ Designated as safety issue: No ]
  • To determine whether adding non-cytotoxic suramin to docetaxel and carboplatin produces survival benefits in African-American patients. [ Time Frame: February 2017 ] [ Designated as safety issue: No ]
  • 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: February 2017 ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: August 2010
Study Completion Date: May 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Suramin
This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.
Drug: Suramin + Docetaxel + 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 + Docetaxel + 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically proven NSCLC, including squamous cell carcinoma.
  • Newly-diagnosed stage IIIB with malignant pleural effusion, stage IV or recurrent disease.
  • 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038752

Locations
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
  More Information

No publications provided

Responsible Party: Optimum Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT01038752     History of Changes
Other Study ID Numbers: Optimum-Suramin-1
Study First Received: December 22, 2009
Last Updated: December 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Optimum Therapeutics, LLC:
NSCLC
suramin
lung cancer
chemotherapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Suramin
Docetaxel
Carboplatin
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents

ClinicalTrials.gov processed this record on July 20, 2014