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The purpose of this study is to evaluate the benefit of adding suramin at a non-cytotoxic dose to carboplatin and docetaxel regimen in the treatment of chemo-naïve patients with non-small cell lung cancer.
The primary objective is to determine the progression free survival for patients with stage III B with malignant pleural effusion or Stage IV NSCLC treated with docetaxel and carboplatin with or without suramin.
The secondary objectives are to compare median overall survival rate, compare overall response rate of patients in both arms, assess toxicity of suramin with docetaxel and carboplatin, determine whether pre-treatment bFGF levels correlate with survival, to determine whether survival benefit from suramin is associated with M phase entry in peripheral blood lymphocytes, and to determine whether adding suramin to docetaxel and carboplatin produces greater survival benefits in African-American patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suramin | Experimental | This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin. |
|
| Standard of care | Placebo Comparator | This group will receive placebo with docetaxel and carboplatin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suramin Drug:Docetaxel Drug: Carboplatin | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria | Insufficient data | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival of Participants | Insufficient Data | First treatment date to date of death |
| Overall Response Rate (Complete Response + Partial Response) of Participants | Insufficient data |
Not provided
Inclusion Criteria:
Histologically or cytologically proven on-small cell lung cancer (NSCLC), including squamous cell carcinoma.
Newly-diagnosed stage IIIB with malignant pleural effusion, stage IV or recurrent disease.
Known central nervous system metastases if patients are asymptomatic and have completed whole brain or stereotactic radiation at least 2 weeks prior or surgery at least 4 weeks prior to starting treatment on this protocol. Must be off dexamethasone at the time of starting treatment.
Must have completed radiotherapy at least two weeks prior to registration. Prior radiation therapy is eligible if patient has a measurable lesion that has not been irradiated.
Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (RECIST criteria).
Lesions that are not considered measurable include the following:
ECOG performance status of 0-1.
Life expectancy ≥ 3 months.
Adequate bone marrow function, absolute neutrophil count ≥1,500/mm3, hemoglobin ≥9.9 gm/dl, and platelet count ≥100,000/mm3.
Adequate liver function defined as bilirubin ≤ 1x upper level of the institutional normal (ULIN). AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. See protocol.
Must have adequate renal function defined as serum creatinine ≤ 2.0 mg/dl or calculated creatinine clearance ≥ 60 ml/min for patients with creatinine levels above 2.0 mg/dl.
Must have recovered from uncontrolled intercurrent illness, including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
Use of adequate contraception (hormonal or barrier method of birth control) for the duration of study participation and continued for at least three months after completing treatment. Non-pregnant status will be determined in all women of childbearing potential.
Age > 18.
Patients must have given written informed consent.
Entry to this study is open to both men and women and to all racial and ethnic subgroups. The goal is to accrue a minimum of 44 patients of African-American ancestry and a maximum of 120 non-African-American patients. Classification of patient race and ancestry will be based on patient's self-identification on the consent form for the clinical trial.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | United States | ||
| Virginia Commonwealth University Massey Cancer Center |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria | Insufficient data | Because 6 of 14 participants were lost to follow up before progression, analysis was not performed. | Posted | 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. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial Effusion | Cardiac disorders | Unrelated to the treatment and determined to be caused by disease progression. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. M. Guillaume Wientjes | Optimum Therapeutics | gwientjes@optimumtx.com |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D013498 | Suramin |
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D009282 | Naphthalenesulfonates |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
|
| Placebo Drug: Docetaxel Drug: Carboplatin | Drug | 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). |
|
|
| Tumor assessment at every other cycle |
| Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin. | Insufficient data. | Day 1 of each cycle; end of treatment visit; at follow-up. |
| Pre-treatment bFGF Levels Correlation With Survival. | Insufficient data. | Before first treatment |
| Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes | Insufficient data. | Randomization date |
| To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients. | Insufficient data. | Randomization date to date of death |
| 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. | Insufficient data. | Randomization date to date of death |
| Richmond |
| Virginia |
| 23298 |
| United States |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Non-small cell lung cancer (NSCLC) Disease Stage at Entry | 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:
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. | Number | participants |
|
| Non-small cell lung cancer (NSCLC) Disease Type | Number | participants |
|
| OG001 |
| 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). |
|
| Secondary | Overall Survival of Participants | Insufficient Data | Because 6 of 14 participants were lost to follow up before progression, analysis was not performed. | Posted | First treatment date to date of death |
|
|
| Secondary | Overall Response Rate (Complete Response + Partial Response) of Participants | Insufficient data | Because 6 of 14 participants were lost to follow up before progression, analysis was not performed. | Posted | Tumor assessment at every other cycle |
|
|
| Secondary | Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin. | Insufficient data. | Because 6 of 14 participants were lost to follow up before progression, analysis was not performed. | Posted | Day 1 of each cycle; end of treatment visit; at follow-up. |
|
|
| Secondary | Pre-treatment bFGF Levels Correlation With Survival. | Insufficient data. | Because 6 of 14 participants were lost to follow up before progression, analysis was not performed. | Posted | Before first treatment |
|
|
| Secondary | Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes | Insufficient data. | Because 6 of 14 participants were lost to follow up before progression, analysis was not performed. | Posted | Randomization date |
|
|
| Secondary | To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients. | Insufficient data. | Because 6 of 14 participants were lost to follow up before progression, analysis was not performed. | Posted | Randomization date to date of death |
|
|
| Secondary | 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. | Insufficient data. | Because 6 of 14 participants were lost to follow up before progression, analysis was not performed. | Posted | Randomization date to date of death |
|
|
| 3 |
| 8 |
| 6 |
| 8 |
| EG001 | 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). | 0 | 6 | 6 | 6 |
|
| Acute Renal Failure | Renal and urinary disorders | Unrelated to the treatment and determined to be caused by disease progression. |
|
| Hematuria | Renal and urinary disorders | Unrelated to treatment or cancer and possibly result of an infection. |
|
| Altered mental status | Psychiatric disorders | Attributed to acute ischemia and not related to treatment. |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Attributed to the progression of disease |
|
| Leukopenia | Blood and lymphatic system disorders |
|
| Infection | Infections and infestations |
|
| Fatigue/asthenia | General disorders |
|
| Thrombosis | Vascular disorders |
|
| Neutropenic Fever | Blood and lymphatic system disorders |
|
| Alopecia | Skin and subcutaneous tissue disorders |
|
| Nausea | General disorders |
|
| Vomiting | General disorders |
|
| Anorexia | Metabolism and nutrition disorders |
|
| Headache | General disorders |
|
| Mayalgias/Arthralgias | Musculoskeletal and connective tissue disorders |
|
| Constipation | General disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Mucositis | Gastrointestinal disorders |
|
| Abdominal Pain/Cramps | General disorders |
|
| Hypersensitivity/Rash | Skin and subcutaneous tissue disorders |
|
| Hyperbilirubinemia | Hepatobiliary disorders |
|
| Transaminitis | Hepatobiliary disorders |
|
| Hearing Loss/Tinnitus | General disorders |
|
| Fluid Retention/Edema | General disorders |
|
| Peripheral Neuropathy | Nervous system disorders |
|
| Seizures | Nervous system disorders |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011083 | Polycyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |