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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.
Must not have
Individuals with the presence of symptomatic CNS metastasis requiring radiation, surgery, or ongoing use of corticosteroids. Untreated or brain metastasis causing any symptoms. Treated brain metastasis must be stable for 4 weeks prior to first dose of study drug and not require steroids for at least 7 days prior to study treatment.
History of allergy or hypersensitivity to albumin-bound paclitaxel, or gemcitabine.
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
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial tests if combining two chemotherapy drugs, Abraxane and Gemcitabine, can treat small cell cancer that has come back or spread after initial treatment. The treatment is for patients whose cancer did not respond to the first round of therapy. The drugs work by stopping cancer cells from growing and spreading. Gemcitabine has been used with other drugs for various cancers, showing positive results in some cases.

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.
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.
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 below
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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.
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My liver tests are within the required limits.
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My cancer is a type of small cell cancer or similar, and it has spread or come back.
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I can take care of myself and am up and about more than half of the day.
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It's been over 3 weeks since my last chemotherapy and 2 weeks since any targeted or immunotherapy.
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My major organs are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My brain metastasis is stable, and I haven't needed steroids for at least 7 days.
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I am not allergic to albumin-bound paclitaxel or gemcitabine.
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I haven't had major heart issues, strokes, or seizures in the last 6 months.
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I have not had major surgery within the last two weeks.
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I do not have any serious infections or illnesses that could worsen with the study treatment.
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I am currently breastfeeding.
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I do not have severe nerve damage in my hands or feet.
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I have been treated with a taxane for small cell lung cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be evaluated every 2 cycles until progression or off treatment (up to 3 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate
Secondary study objectives
Overall Survival
Progression-Free Survival
Time to Progression

Side effects data

From 2016 Phase 3 trial • 50 Patients • NCT02019277
70%
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%
Lacrimation increased
8%
Febrile neutropenia
8%
Rash pustular
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%
Device related infection
2%
Gastroenteritis
2%
Wound infection
2%
Femur fracture
2%
Breast cancer
2%
Syncope
2%
Psychotic disorder
2%
Dermatitis bullous
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Paclitaxel
FDA approved
Gemcitabine
FDA approved

Find a Location

Who is running the clinical trial?

Celgene CorporationIndustry Sponsor
445 Previous Clinical Trials
58,614 Total Patients Enrolled
Muhammad FurqanLead Sponsor
4 Previous Clinical Trials
95 Total Patients Enrolled
Muhhamad Furqan, MDPrincipal InvestigatorUniversity of Iowa

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02769832 — Phase 2
Lung Cancer Research Study Groups: Nab-Paclitaxel with Gemcitabine
Lung Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT02769832 — Phase 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02769832 — Phase 2
~3 spots leftby Nov 2025
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