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Anti-metabolites
Docetaxel With/Without Oblimersen for Lung Cancer
Phase 2 & 3
Waitlist Available
Research Sponsored by Genta Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Relapsed or refractory disease
No uncontrolled diabetes mellitus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will compare the effectiveness of docetaxel with or without oblimersen in treating patients with relapsed or refractory non-small cell lung cancer.
Who is the study for?
This trial is for adults over 18 with non-small cell lung cancer that's come back or hasn't responded to treatment. They should have had only one prior chemo regimen, be in fairly good health, not pregnant, and able to use contraception. People with severe diseases, certain allergies, uncontrolled conditions like heart failure or diabetes, active infections or cancers other than NSCLC can't join.Check my eligibility
What is being tested?
The study is testing if adding a drug called Oblimersen to the chemotherapy drug Docetaxel helps more in treating non-small cell lung cancer compared to using Docetaxel alone. Patients are randomly assigned to either get both drugs or just Docetaxel.See study design
What are the potential side effects?
Docetaxel can cause side effects like low blood counts leading to infection risk, allergic reactions, hair loss and nail changes. Oblimersen might increase these effects by making cells more sensitive to chemotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition has returned or didn't respond to treatment.
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My diabetes is under control.
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I do not have any major health issues.
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I do not have any disabilities that would stop me from joining the study.
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My cancer can be measured and has not been treated with radiation.
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I have had one chemotherapy treatment for my cancer.
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I am 18 years old or older.
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I am able to get out of my bed or chair and move around.
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My liver functions are within normal limits and I don't have chronic hepatitis or cirrhosis.
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My kidney function, measured by creatinine, is within normal limits.
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My heart condition does not severely limit my daily activities.
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I do not have severe lung disease or need oxygen due to lung surgery.
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I do not have HIV, active infections, or autoimmune diseases.
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I do not have any other active cancer.
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I do not have seizures that my medication cannot control.
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I do not have severe numbness or pain in my hands or feet.
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I do not have an active stomach ulcer.
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I do not have any mental health conditions that would prevent me from understanding or following the study's requirements.
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I have been diagnosed with non-small cell lung cancer.
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My cancer is at stage IIIB or IV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Find a Location
Who is running the clinical trial?
Genta IncorporatedLead Sponsor
30 Previous Clinical Trials
1,670 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,153 Total Patients Enrolled
Deborah BracciaStudy ChairGenta Incorporated
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases or leptomeningeal disease that hasn't been treated or is causing symptoms.I have had a condition where my lymphocytes grow abnormally.I am not receiving any other cancer treatments.I have never received an organ transplant.I have not received second-line EGFR therapy.I have never been treated with oblimersen.My heart condition does not severely limit my daily activities.I do not have any current infections.I have a history of cancer.I haven't had cancer in the last 5 years, except for skin cancer.I do not have severe fluid buildup in my lungs due to lung cancer.My heart condition is under control.I am not currently receiving any experimental or cancer treatments.My cancer can be measured and has not been treated with radiation.I have had one chemotherapy treatment for my cancer.I have good veins for a long-term IV treatment.I do not have chronic cirrhosis.I do not have severe lung problems.I do not have an active autoimmune disease.I am not currently on any biologic therapy for cancer.I have never been treated with docetaxel.I do not have any major health issues.My liver functions are within normal limits and I don't have chronic hepatitis or cirrhosis.My heart condition does not severely limit my daily activities.My diabetes is under control.I do not have any disabilities that would stop me from joining the study.I am not on blood thinners, except possibly low-dose warfarin for a central line.My condition has returned or didn't respond to treatment.I do not have chronic hepatitis.I am 18 years old or older.My kidney function, measured by creatinine, is within normal limits.I do not have severe lung disease or need oxygen due to lung surgery.I do not have HIV, active infections, or autoimmune diseases.I am able to get out of my bed or chair and move around.I do not have any other active cancer.I do not have seizures that my medication cannot control.I do not have severe numbness or pain in my hands or feet.I do not have an active stomach ulcer.I do not have any mental health conditions that would prevent me from understanding or following the study's requirements.I have been diagnosed with non-small cell lung cancer.I do not need oxygen after lung surgery.My cancer is at stage IIIB or IV.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you give me a breakdown of how many sites are participating in this research project?
"Jonsson Comprehensive Cancer Center, UCLA in Los Angeles, Pacific Hematology/Oncology in San Francisco, and Medical Oncology Care Associates in Orange, are some of the 39 hospitals currently running this trial."
Answered by AI
Does this trial have any vacancies for new participants?
"The listed clinical trial on clinicaltrials.gov is no longer recruiting patients. Although, there are 2082 other trials that may be of interest and are currently recruiting. This particular study was first posted on October 1st, 2001 and was last edited on January 3rd, 2014."
Answered by AI
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