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Anti-metabolites
Abraxane + Gemcitabine for Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Muhhamad Furqan, MD
Research Sponsored by Muhammad Furqan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Renal function: serum creatinine ≤ 1.5 x ULN.
Prior definitive XRT is allowed if it has been 2 weeks since the end of definitive XRT. For palliative XRT, protocol-specified treatment can begin at minimum 48 hours after completion of radiation. Lesions within the XRT field can only be used as target lesions if definite progression has been demonstrated since the completion of radiation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)
Awards & highlights
Study Summary
This trial is testing whether combining Abraxane and Gemcitabine will be effective in treating small cell cancer that has progressed after one line of treatment.
Who is the study for?
Adults over 18 with small cell lung cancer that's come back after one treatment can join. They need good organ function, no major surgery or brain metastasis symptoms recently, and must not be pregnant or nursing. Participants should agree to use contraception and have measurable cancer growth per specific criteria.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining two chemotherapy drugs, Abraxane (Nab-paclitaxel) and Gemcitabine, in treating relapsed small cell lung cancer. Patients previously treated but now showing progression are eligible for this combination therapy.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs, fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems, liver issues indicated by abnormal tests results, nerve damage causing numbness or pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is normal, based on my creatinine levels.
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I finished my main radiation therapy 2 weeks ago or my palliative radiation 48 hours ago.
Select...
My liver tests are within the required limits.
Select...
My cancer is a type of small cell cancer or similar, and it has spread or come back.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
It's been over 3 weeks since my last chemotherapy and 2 weeks since any targeted or immunotherapy.
Select...
My major organs are functioning well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Secondary outcome measures
Overall Survival
Progression-Free Survival
Time to Progression
Side effects data
From 2016 Phase 3 trial • 50 Patients • NCT0201927770%
Diarrhoea
68%
Fatigue
56%
Neuropathy peripheral
54%
Alopecia
52%
Rash
46%
Nausea
38%
Upper respiratory tract infection
36%
Myalgia
34%
Vomiting
34%
Headache
28%
Muscle spasms
24%
Nail disorder
24%
Gastrooesophageal reflux disease
24%
Epistaxis
24%
Arthralgia
22%
Pain in extremity
20%
Back pain
20%
Urinary tract infection
18%
Dizziness
18%
Cough
18%
Constipation
16%
Neutropenia
16%
Dry skin
14%
Pyrexia
14%
Paronychia
14%
Dysgeusia
14%
Oropharyngeal pain
14%
Pruritus
14%
Hot flush
12%
Hypertension
12%
Dry eye
12%
Stomatitis
12%
Decreased appetite
12%
Musculoskeletal pain
12%
Insomnia
12%
Dyspnoea
10%
Peripheral sensory neuropathy
10%
Abdominal pain
10%
Mucosal inflammation
10%
Lethargy
8%
Febrile neutropenia
8%
Rash pustular
8%
Lacrimation increased
8%
Chills
8%
Anaemia
8%
Oedema peripheral
8%
Oral candidiasis
8%
Sinusitis
8%
Anxiety
8%
Rhinorrhoea
8%
Acne
8%
Erythema
6%
Musculoskeletal chest pain
6%
Injection site reaction
6%
Skin lesion
6%
Conjunctivitis
6%
Nail infection
6%
Chest pain
6%
Tachycardia
6%
Abdominal pain upper
6%
Dry mouth
6%
Dyspepsia
6%
Chest discomfort
6%
Pain
6%
Hypocalcaemia
6%
Bone pain
6%
Depression
6%
Dyspnoea exertional
6%
Dermatitis acneiform
6%
Lymphoedema
6%
Weight decreased
6%
Tooth extraction
4%
Pulmonary embolism
4%
Cellulitis
2%
Psychotic disorder
2%
Syncope
2%
Dermatitis bullous
2%
Gastroenteritis
2%
Femur fracture
2%
Breast cancer
2%
Device related infection
2%
Wound infection
2%
Cardiac failure
2%
Drug hypersensitivity
2%
Gastritis
2%
Dermatomyositis
2%
Oesophagitis
2%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab, Pertuzumab, and Taxane
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nab-Paclitaxel with GemcitabineExperimental Treatment2 Interventions
Nab-paclitaxel 100 mg/m2, day 1 and day 8 of a 21-day cycle Gemcitabine 1000 mg/m2, day 1 and day 8 of a 21-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Paclitaxel
FDA approved
Find a Location
Who is running the clinical trial?
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,204 Total Patients Enrolled
Muhammad FurqanLead Sponsor
4 Previous Clinical Trials
95 Total Patients Enrolled
Muhhamad Furqan, MDPrincipal InvestigatorUniversity of Iowa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is normal, based on my creatinine levels.I finished my main radiation therapy 2 weeks ago or my palliative radiation 48 hours ago.My liver tests are within the required limits.You must have at least one specific area of your body that can be measured to see how the treatment is working.I haven't had active cancer, except for certain skin, prostate, cervix, breast, or bladder cancers, in the last year.My brain metastasis is stable, and I haven't needed steroids for at least 7 days.I am not allergic to albumin-bound paclitaxel or gemcitabine.I haven't had major heart issues, strokes, or seizures in the last 6 months.I have not had major surgery within the last two weeks.My cancer progressed after my first chemotherapy, but I may have had other treatments like immunotherapy.I agree to follow the study's rules on not getting pregnant or fathering a child.My cancer is a type of small cell cancer or similar, and it has spread or come back.I can take care of myself and am up and about more than half of the day.I am using or willing to use approved birth control methods if of childbearing potential.Your blood tests show a normal level of white blood cells, platelets, and hemoglobin.I agree to use birth control during and for 6 months after the study.I am willing and able to give my consent for treatment.I do not have any serious infections or illnesses that could worsen with the study treatment.I am currently breastfeeding.I am 18 years old or older.It's been over 3 weeks since my last chemotherapy and 2 weeks since any targeted or immunotherapy.My major organs are functioning well.You have a mental health condition that could make it hard for you to follow the study's rules.I do not have severe nerve damage in my hands or feet.I have been treated with a taxane for small cell lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Nab-Paclitaxel with Gemcitabine
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
What other scientific research has there been on Nab-paclitaxel?
"At the moment, there are 1191 clinical trials underway for Nab-paclitaxel. 334 of those studies are in their third and final phase. Although many of the trials for Nab-paclitaxel originate in Shanghai, China, there are 60103 locations running trials for this treatment worldwide."
Answered by AI
Who would be the most ideal candidates for this medical study?
"This trial is admitting 32 participants with small cell lung cancer (sclc) between the ages of 18 and 99. Most importantly, patients should meet the following criteria: Before study therapy, a minimum of 21 days must have elapsed since any prior chemotherapy and 2 weeks from the last dose of prior targeted or immunotherapy., Histologically or cytologically confirmed SCLC SCLC or small cell cancer from other organs or poorly differentiated neuroendocrine tumors that are treated like small cell cancer. This study is for patients with metastatic or recurrent disease., ECOG performance status 0-2, Progression during or after prior first line chemotherapy"
Answered by AI
What are some common conditions that Nab-paclitaxel is used to treat?
"Nab-paclitaxel is used to treat non-small cell lung cancer that has spread to other parts of the body. It can also be used to manage metastatic bladder cancer, urinary bladder, and mediastinitis."
Answered by AI
For what age bracket is this study searching for participants?
"This study requires that applicants between the ages of 18 to 99. There are a total 61 clinical trials for people under the age of 18 and 1476 for patients over 65."
Answered by AI
Does Nab-paclitaxel have the stamp of approval from the FDA?
"Nab-paclitaxel is currently in Phase 2 of clinical trials. Although there is some evidence supporting its safety, more data needs to be collected regarding the efficacy of this medication."
Answered by AI
Are we still enrolling participants for this research project?
"This study is not presently looking for new recruits. It was first posted on 8/29/2016 and updated as recently as 6/4/2021. If you are interested in other studies, 315 trials for patients with small cell lung cancer (sclc) and 1191 Nab-paclitaxel trials are currently ongoing and recruiting respectively."
Answered by AI
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