Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer

Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy

The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non Small Cell Lung
• Intervention / Treatment: Drug: Docetaxel; Drug: Docetaxel; Drug: Suramin

Detailed Description

The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.

Secondary objectives include:

• To compare response rate of patients in both treatment arms
• To compare overall survival of patients in both treatment arms
• To compare toxicity in both treatment arms
• To determine whether the survival benefit from suramin is associated with reduced M-phase entry in peripheral blood lymphocytes

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Carbone Comprehensive Cancer Center
    • Milwaukee, Wisconsin, United States
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pathologically proven diagnosis of non-small cell lung cancer
• Documented disease progression after first-line chemotherapy for non-small cell lung cancer
• Stable and treated CNS metastasis is allowed
• Radiation must be completed at least 2 weeks prior to starting protocol treatment
• Major surgery must be completed at least 4 weeks prior to starting protocol treatment
• ECOG performance status 0-2
• Sexually active patients must use adequate contraception
• Adequate bone marrow function
• Adequate renal function
• Adequate liver function

Exclusion Criteria:

• Severe hypersensitivity reaction to docetaxel
• Pre-existing grade 3 or 4 neuropathy
• Women who are pregnant or breastfeeding
• Uncontrolled intercurrent illness
• Receipt of 3 or more prior chemotherapy regimens

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Docetaxel	Drug: Docetaxel; IV over 60 minutes, 75 mg/m2; Other Names: Taxotere; Drug: Docetaxel; IV over 60 minutes. 56 mg/m2; Other Names: Taxotere
EXPERIMENTAL: Docetaxel plus Suramin	Drug: Docetaxel; IV over 60 minutes, 75 mg/m2; Other Names: Taxotere; Drug: Docetaxel; IV over 60 minutes. 56 mg/m2; Other Names: Taxotere; Drug: Suramin; IV over 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival in Months	Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rate Per RECIST 1.1 Criteria	Response rate per RECIST 1.1, as follows: Complete response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis Partial response (PR): At least 30% decrease in the sum of longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters Progressive disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. (Two lesions increasing from 2mm to 3mm, for example, does not qualify). Stable disease (SD): Neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for PD	Up to 1 year
Overall Survival	Compare overall survival of participants in both treatment arms.	Up to 50 months
Number of Participants With Toxicity/Adverse Events From Treatment	The investigators will compare the toxicity profiles of the two arms of therapy to determine if the docetaxel + suramin has a more favorable toxicity profile than docetaxel alone. This count includes only adverse events considered definitely, probably, or possibly due to treatment.	Up to 2 years
Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.	The investigators hypothesize that suramin in combination with docetaxel improves response rates and survival by increasing the cancer cell population in the M phase of the cell cycle. The G2-M checkpoint control score, defined as (%M-phase arrested cells after cisplatin+suramin)/(%M-phase arrested cells after cisplatin), is an indicator of the effect of suramin on cell accumulation in the M-phase. G2-M checkpoint control was evaluated as a predictor of PFS and OS in participant receiving suramin by linear correlation.	Baseline

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Medical College of Wisconsin; Ohio State University; Optimum Therapeutics, LLC
• Investigators: Study Chair: Rafael Santana-Davila, MD, Medical College of Wisconsin

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2012
• Primary Completion (ACTUAL): June 11, 2015
• Study Completion (ACTUAL): June 16, 2016

Study Registration Dates

• First Submitted: June 25, 2012
• First Submitted That Met QC Criteria: August 20, 2012
• First Posted (ESTIMATE): August 23, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Third line; Second line; Carcinoma, non small cell lung
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antiprotozoal Agents; Antiparasitic Agents; Antinematodal Agents; Anthelmintics; Trypanocidal Agents; Docetaxel; Suramin
• Other Study ID Numbers: CO11508; A534260 (Other Identifier: UW Madison); SMPH/MEDICINE/MEDICINE*H (Other Identifier: UW Madison); 2012-0118 (OTHER: Institutional Review Board); NCI-2012-01113 (REGISTRY: NCI Trial ID)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No