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

Phase 2

Completed

• Conditions: Carcinoma, Non Small Cell Lung
• Interventions: Drug: Docetaxel; Drug: Suramin

• Registration Number: NCT01671332
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-23
• Primary Completion: 2015-06-11
• Study Completion: 2016-06-16
• Disposition First Submitted: 2016-06-29
• Disposition First Submitted QC: 2016-08-05
• Disposition First Posted: 2016-09-02
• Results First Submitted: 2019-10-22
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-07
• Last Update Submitted: 2020-05-07
• Results First Posted: 2020-05-12
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docetaxel	Docetaxel	-
Docetaxel plus Suramin	Suramin	-
Docetaxel plus Suramin	Docetaxel	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival in Months	Up to 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Response Rate Per RECIST 1.1 Criteria	Up to 1 year	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
Overall Survival	Up to 50 months	Compare overall survival of participants in both treatment arms.
Number of Participants With Toxicity/Adverse Events From Treatment	Up to 2 years	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.
Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.	Baseline	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.

Trial Locations

Locations (2)

University of Wisconsin Carbone Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States