Trial Outcomes & Findings for Evaluation of Non-cytotoxic Suramin as a Chemosensitizer in Non-small Cell Lung Cancer (NCT NCT01038752)

NCT ID: NCT01038752

Last Updated: 2015-05-21

Results Overview

Insufficient data

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

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.

Results posted on

2015-05-21

Participant Flow

A total of 164 subjects were expected to be enrolled in this study; however, only a total of 14 subjects were enrolled at two active sites. Site 001 (Virginia Commonwealth University) enrolled 4 subjects and site 002 (Cook County) enrolled 10 subjects for a total of 14 subjects.

Participant milestones

Participant milestones
Measure	Suramin This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin. 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).	Standard of Care This group will receive placebo with docetaxel and carboplatin. 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).
Overall Study STARTED	8	6
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Suramin This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin. 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).	Standard of Care This group will receive placebo with docetaxel and carboplatin. 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).
Overall Study Tumor Progression	2	2
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Suramin n=8 Participants This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin. 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).	Standard of Care n=6 Participants This group will receive placebo with docetaxel and carboplatin. 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).	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants	2 Participants n=107 Participants	7 Participants n=206 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants	4 Participants n=107 Participants	7 Participants n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	1 Participants n=107 Participants	7 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=99 Participants	6 Participants n=107 Participants	14 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	5 Participants n=99 Participants	5 Participants n=107 Participants	10 Participants n=206 Participants
Race (NIH/OMB) White	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Non-small cell lung cancer (NSCLC) Disease Stage at Entry IIIB	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants
Non-small cell lung cancer (NSCLC) Disease Stage at Entry IV	7 participants n=99 Participants	6 participants n=107 Participants	13 participants n=206 Participants
Non-small cell lung cancer (NSCLC) Disease Type Squamous	2 participants n=99 Participants	2 participants n=107 Participants	4 participants n=206 Participants
Non-small cell lung cancer (NSCLC) Disease Type Nonsquamous	6 participants n=99 Participants	4 participants n=107 Participants	10 participants n=206 Participants

PRIMARY outcome

Timeframe: 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.