Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Docetaxel

Suramin

Tubulin Modulators

Antimitotic Agents

Anthelmintics

Antiparasitic Agents

Antiprotozoal Agents

Anne M Traynor, MD

Rafael Santana-Davila, MD

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.

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

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

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.

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

Compare overall survival of participants in both treatment arms.

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.

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.

Medical College of Wisconsin

Optimum Therapeutics, LLC

Ohio State University

University of Wisconsin, Madison

AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.

Docetaxel: IV over 60 minutes, 75 mg/m2

Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.

Suramin: IV over 30 minutes

Docetaxel: IV over 60 minutes. 56 mg/m2

Docetaxel Plus Suramin

Total

18-39 years

40-49 years

50-59 years

60-69 years

70-79 years

80-89 years

Age, Customized

Sex: Female, Male

White, Not of Hispanic Origin

Black or African American, Not of Hispanic Origin

Hispanic or Latino

Asian

Native Hawaiian or Other Pacific Islander

American Indian or Alaska Native

Race/Ethnicity, Customized

United States

Region of Enrollment

Anne Traynor

The 13 participants that crossed over to the Docetaxel plus Suramin arm did so after progressing on the standard arm. Their progression-free survival was therefore purely determined by the arm of randomization and not influenced by the cross-over.

Progression-free Survival in Months

Partial Response

Stable Disease

Progressive Disease

Not Assessed

The 13 participants that crossed over to the Docetaxel plus Suramin arm did so after progressing on the standard arm. Their response rate was determined by the arm of randomization and not influenced by the cross-over.

Response Rate Per RECIST 1.1 Criteria

The 13 participants that crossed over did so after progressing on the standard arm. The overall survival was determined for the arm of randomization without regard of cross-over. Cross-over was provided as option for participants to have the possible benefit of the new treatment.

Overall Survival

The 13 participants that crossed over did so after progressing on the standard arm. Reported here are the number of participants who experienced adverse events on the arm of randomization.

Number of Participants With Toxicity/Adverse Events From Treatment

All participants who yielded good quality PBL samples were included.

Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.

Overall Study

Spots Global Cancer Trial Database for Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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