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

Carcinoma, Non Small Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671332
• Other study ID #: CO11508
• Secondary ID: A534260SMPH/MEDI
• Status: Completed
• Phase: Phase 2
• Start date: June 2012
• Est. completion date: June 16, 2016

Study information

• Verified date: May 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 16, 2016
• Est. primary completion date: June 11, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non Small Cell Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Docetaxel
IV over 60 minutes, 75 mg/m2
• Suramin
IV over 30 minutes
• Docetaxel
IV over 60 minutes. 56 mg/m2

Locations

Country	Name	City	State
United States	University of Wisconsin Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (4)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Medical College of Wisconsin, Ohio State University, Optimum Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall Survival	Compare overall survival of participants in both treatment arms.	Up to 50 months
Secondary	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
Secondary	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

External Links

•   University of Wisconsin Carbone Cancer Center