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Pharmaceutical company no longer manufacturing investigational product.
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| Name | Class |
|---|---|
| Genta Incorporated | INDUSTRY |
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The goal of this clinical research is to learn if the combination of Genasense (oblimersen), carboplatin, and paclitaxel (GCP) can help to control metastatic uveal melanoma. The safety of this combination will also be studied.
Study Drugs:
Oblimersen is designed to stop the body from making a protein that makes melanoma cells resistant to chemotherapy drugs. This may make carboplatin and/or paclitaxel more effective.
Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.
Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive oblimersen by vein over about 1 hour (+/- 5 minutes) on Days 1, 3, and 5 of each 21-day study "cycle." You will receive dexamethasone by vein over about 30 minutes before you receive oblimersen to help prevent side effects. You will take ibuprofen by mouth about 30 minutes before you receive oblimersen.
You will receive paclitaxel by vein over about 3 hours (+/- 5 minutes) on Day 3 of each cycle.
You will receive carboplatin by vein over about 30 minutes (+/- 5 minutes) on Day 3 of each cycle.
Before you receive each of these drugs, you may receive other drugs to help prevent side effects (such as nausea, vomiting, fever, and/or body aches). You may need to receive some of these drugs for some time after you receive the study drugs. Your doctor will tell you more about each of these drugs, about how they are given, and about any possible risks of receiving them.
Study Visits:
Within 3 days before each cycle, blood (about 1 tablespoon) will be drawn for routine tests.
On Day 1 of each cycle:
Each week while you are on study, blood (about 1 teaspoon) will be drawn for routine tests.
Every 6 weeks, you will have the same imaging (CT and/or MRI) scans that you had at screening to check the status of the disease. If the doctor thinks it is needed, you will have a bone scan.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.
Your participation on the study will be over once you have completed the end-of-treatment visit and follow-up.
End-of-Treatment Visit:
After you stop receiving the study drugs, the following tests and procedures will be performed:
Follow-up:
Every 3 months for up to 2 years after you stop receiving the study drugs, you will be called and asked about how you are doing and about any other drugs you may be receiving. Each call will last about 3 minutes.
This is an investigational study. Carboplatin and paclitaxel are FDA approved and commercially available for the treatment of a variety of cancers including breast, lung, and ovarian cancers. Oblimersen is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genasense + Paclitaxel + Carboplatin | Experimental | Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genasense | Drug | 900 mg by vein over 1 hour on Days 1, 3, and 5 of a 21 day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response) | Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s | Following two 3-week cycles |
| Number of Participants With Response | Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s | Following two 3-week cycles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sapna P. Patel, MD | UT MD Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| UT MD Anderson Cancer Center website | View source |
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Study was terminated early due to decision by drug sponsor to no longer manufacture investigational drug.
Recruitment Period: December 6, 2010 to November 05, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Genasense + Paclitaxel + Carboplatin | Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Due to inadequate enrollment of study participants, no statistical analysis were able to be performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Genasense + Paclitaxel + Carboplatin | Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response) | Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s | The efficacy-evaluable population defined as all subjects who completed at least two cycles of therapy and had at least one post-screening assessment of target and non-target lesions. Due to inadequate enrollment of study participants, no statistical analyses were able to be performed. | Posted | Number | Percentage of Participants | Following two 3-week cycles |
Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
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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 | Genasense + Paclitaxel + Carboplatin | Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sapna P. Patel, MD / Assistant Professor | UT MD Anderson Cancer Center | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C408162 | oblimersen |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel | Drug | 175 mg/m^2 by vein over 3 hours on Day 3 of a 21 day cycle following Genasense. |
|
|
| Carboplatin | Drug | Carboplatin starting dose in mg (AUC= 6) is administered over 30 minutes IV Piggyback (IVPB). Carboplatin will be dosed after Paclitaxel dose on Day 3 every 3 weeks. The total dose of Carboplatin is calculated using a formula based upon a participant's glomerular filtration rate (GFR in mL/min) and Carboplatin target area under the concentration (AUC). |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Number of Participants With Response | Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s | The efficacy-evaluable population defined as all subjects who completed at least two cycles of therapy and had at least one post-screening assessment of target and non-target lesions. | Posted | Number | Participants | Following two 3-week cycles |
|
|
|
| 0 |
| 7 |
| 7 |
| 7 |
| Alanine aminotransferase increased | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Alkaline phosphatase increased | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Alopecia | General disorders | CTCAE (4.03) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Anorexia | Psychiatric disorders | CTCAE (4.03) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Blood bilirubin increased | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.03) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.03) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.03) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment | 1 event = Grade 3 |
|
| Cough | General disorders | CTCAE (4.03) | Systematic Assessment |
|
| Creatinine increased | Renal and urinary disorders | CTCAE (4.03) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.03) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Dizziness | Ear and labyrinth disorders | CTCAE (4.03) | Systematic Assessment | 1 event = Grade 3 |
|
| Dry mouth | General disorders | CTCAE (4.03) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Edema limbs | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
|
| Eye disorders | Eye disorders | CTCAE (4.03) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.03) | Systematic Assessment | 1 event = Grade 3 |
|
| Febrile neutropenia | Infections and infestations | CTCAE (4.03) | Systematic Assessment | Grade 3 |
|
| Fever | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
|
| Gait disturbance | Nervous system disorders | CTCAE (4.03) | Systematic Assessment | Loss of balance |
|
| Gastrointestinal disorders | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
|
| Hallucinations | Nervous system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Hot flashes | General disorders | CTCAE (4.03) | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | CTCAE (4.03) | Systematic Assessment | 2 events = Grade 3; 1 event = Grade 4 |
|
| Hyperkalemia | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Hyperuricemia | Renal and urinary disorders | CTCAE (4.03) | Systematic Assessment |
|
| Hypoalbuminemia | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Hypokalemia | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Hypomagnesemia | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Hyponatremia | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment | 1 event = Grade 3 |
|
| Hypotension | Cardiac disorders | CTCAE (4.03) | Systematic Assessment | Grade 3 |
|
| Infections and infestations | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
|
| Lymphocyte count decreased | Immune system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Mucositis oral | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
|
| Nausea | General disorders | CTCAE (4.03) | Systematic Assessment |
|
| Neutrophil count decreased | Immune system disorders | CTCAE (4.03) | Systematic Assessment | 2 events = Grade 3; 2 events = Grade 4 |
|
| Pain | General disorders | CTCAE (4.03) | Systematic Assessment | l.thorax |
|
| Pain | General disorders | CTCAE (4.03) | Systematic Assessment | lower back |
|
| Pain | General disorders | CTCAE (4.03) | Systematic Assessment | Abdominal |
|
| Pain | General disorders | CTCAE (4.03) | Systematic Assessment | gr. 1 BL pain |
|
| Pain | General disorders | CTCAE (4.03) | Systematic Assessment | joint pains |
|
| Pain | General disorders | CTCAE (4.03) | Systematic Assessment | 1 event = Grade 3 |
|
| Pain | General disorders | CTCAE (4.03) | Systematic Assessment | sharp joint pains |
|
| Pain | General disorders | CTCAE (4.03) | Systematic Assessment | Lt nares through eye |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
|
| Platelet count decreased | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment | 1 event = Grade 3 |
|
| Pruritus | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
|
| Syncope | Cardiac disorders | CTCAE (4.03) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.03) | Systematic Assessment | 1 event = Grade 3 |
|
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.03) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | CTCAE (4.03) | Systematic Assessment |
|
| Vomiting | General disorders | CTCAE (4.03) | Systematic Assessment | 1 event = Grade 3 |
|
| Weight loss | General disorders | CTCAE (4.03) | Systematic Assessment |
|
| White blood cell decreased | Immune system disorders | CTCAE (4.03) | Systematic Assessment | 3 events = Grade 3 |
|
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| Title | Measurements |
|---|---|
|
| Stable Disease (SD) |
|