Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 19 for:    NAPHURIDE OR SURAMIN SODIUM OR CI-1003 OR SURAMIN HEXASODIUM OR SURAMIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01038752
Recruitment Status : Terminated
First Posted : December 24, 2009
Results First Posted : October 21, 2014
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Optimum Therapeutics, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Interventions Drug: Suramin Drug:Docetaxel Drug: Carboplatin
Drug: Placebo Drug: Docetaxel Drug: Carboplatin
Enrollment 14
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Suramin Standard of Care
Hide Arm/Group Description

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).

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).

Period Title: Overall Study
Started 8 6
Completed 3 1
Not Completed 5 5
Reason Not Completed
Tumor Progression             2             2
Lost to Follow-up             3             3
Arm/Group Title Suramin Standard of Care Total
Hide Arm/Group Description

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).

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 of all reporting groups
Overall Number of Baseline Participants 8 6 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  62.5%
2
  33.3%
7
  50.0%
>=65 years
3
  37.5%
4
  66.7%
7
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
Female
2
  25.0%
5
  83.3%
7
  50.0%
Male
6
  75.0%
1
  16.7%
7
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
8
 100.0%
6
 100.0%
14
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  62.5%
5
  83.3%
10
  71.4%
White
3
  37.5%
1
  16.7%
4
  28.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Non-small cell lung cancer (NSCLC) Disease Stage at Entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
IIIB 1 0 1
IV 7 6 13
[1]
Measure Description:

Stage I: The cancer is confined only to the lungs.

Stage II: The cancer is in the lung and nearby lymph nodes.

Stage III: Cancer is found in the lung and in the lymph nodes in the middle of the chest. There are two subtypes:

  • A: Cancer has spread only to lymph nodes on the same side of the chest where the cancer started.
  • B: Cancer has spread to the lymph nodes on the opposite side of the chest, or above the collar bone.

Stage IV: When the cancer has metastasized to both lungs, to fluid in the area around the lungs, or to another part of the body, such as the liver or other organs.

Non-small cell lung cancer (NSCLC) Disease Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
Squamous 2 2 4
Nonsquamous 6 4 10
1.Primary Outcome
Title Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria
Hide Description Insufficient data
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.
Arm/Group Title Suramin Standard of Care
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Survival of Participants
Hide Description Insufficient Data
Time Frame First treatment date to date of death
Hide Outcome Measure Data
Hide Analysis Population Description
Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.
Arm/Group Title Suramin Standard of Care
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Response Rate (Complete Response + Partial Response) of Participants
Hide Description Insufficient data
Time Frame Tumor assessment at every other cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.
Arm/Group Title Suramin Standard of Care
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin.
Hide Description Insufficient data.
Time Frame Day 1 of each cycle; end of treatment visit; at follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.
Arm/Group Title Suramin Standard of Care
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Pre-treatment bFGF Levels Correlation With Survival.
Hide Description Insufficient data.
Time Frame Before first treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.
Arm/Group Title Suramin Standard of Care
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes
Hide Description Insufficient data.
Time Frame Randomization date
Hide Outcome Measure Data
Hide Analysis Population Description
Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.
Arm/Group Title Suramin Standard of Care
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients.
Hide Description Insufficient data.
Time Frame Randomization date to date of death
Hide Outcome Measure Data
Hide Analysis Population Description
Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.
Arm/Group Title Suramin Standard of Care
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Greater Survival Benefits in African-American Patients Compared to Non-African-American Patients.
Hide Description Insufficient data.
Time Frame Randomization date to date of death
Hide Outcome Measure Data
Hide Analysis Population Description
Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.
Arm/Group Title Suramin Standard of Care
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Suramin Standard of Care
Hide Arm/Group Description

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).

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).

All-Cause Mortality
Suramin Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Suramin Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/8 (37.50%)      0/6 (0.00%)    
Cardiac disorders     
Pericardial Effusion [1]  1/8 (12.50%)  1 0/6 (0.00%)  0
Psychiatric disorders     
Altered mental status [2]  1/8 (12.50%)  1 0/6 (0.00%)  0
Renal and urinary disorders     
Acute Renal Failure [1]  1/8 (12.50%)  1 0/6 (0.00%)  0
Hematuria [3]  1/8 (12.50%)  1 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea [4]  1/8 (12.50%)  1 0/6 (0.00%)  0
[1]
Unrelated to the treatment and determined to be caused by disease progression.
[2]
Attributed to acute ischemia and not related to treatment.
[3]
Unrelated to treatment or cancer and possibly result of an infection.
[4]
Attributed to the progression of disease
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Suramin Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/8 (75.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders     
Anemia  5/8 (62.50%)  5 6/6 (100.00%)  23
Leukopenia  3/8 (37.50%)  3 2/6 (33.33%)  2
Neutropenic Fever  1/8 (12.50%)  1 0/6 (0.00%)  0
Gastrointestinal disorders     
Diarrhea  2/8 (25.00%)  2 0/6 (0.00%)  0
Mucositis  0/8 (0.00%)  0 0/6 (0.00%)  0
General disorders     
Fatigue/asthenia  5/8 (62.50%)  11 5/6 (83.33%)  22
Nausea  5/8 (62.50%)  9 1/6 (16.67%)  1
Vomiting  3/8 (37.50%)  4 0/6 (0.00%)  0
Headache  0/8 (0.00%)  0 1/6 (16.67%)  8
Constipation  3/8 (37.50%)  3 0/6 (0.00%)  0
Abdominal Pain/Cramps  2/8 (25.00%)  2 0/6 (0.00%)  0
Hearing Loss/Tinnitus  0/8 (0.00%)  0 1/6 (16.67%)  1
Fluid Retention/Edema  1/8 (12.50%)  1 2/6 (33.33%)  4
Hepatobiliary disorders     
Hyperbilirubinemia  0/8 (0.00%)  0 0/6 (0.00%)  0
Transaminitis  0/8 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations     
Infection  2/8 (25.00%)  2 0/6 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  5/8 (62.50%)  6 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Mayalgias/Arthralgias  1/8 (12.50%)  1 2/6 (33.33%)  4
Nervous system disorders     
Peripheral Neuropathy  1/8 (12.50%)  1 1/6 (16.67%)  2
Seizures  1/8 (12.50%)  1 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1/8 (12.50%)  5 1/6 (16.67%)  4
Hypersensitivity/Rash  0/8 (0.00%)  0 1/6 (16.67%)  5
Vascular disorders     
Thrombosis  3/8 (37.50%)  6 0/6 (0.00%)  0
The study was terminated prematurely due to the loss of follow-up of 6 of 14 participants before progression and slow accrual. Due to the resulting small numbers, no analysis was attempted.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. M. Guillaume Wientjes
Organization: Optimum Therapeutics
Responsible Party: Optimum Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT01038752     History of Changes
Other Study ID Numbers: Optimum-Suramin-1
First Submitted: December 22, 2009
First Posted: December 24, 2009
Results First Submitted: October 15, 2014
Results First Posted: October 21, 2014
Last Update Posted: May 21, 2015