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Anti-metabolites

nab-Paclitaxel + Gemcitabine for Sarcoma

Phase 2
Recruiting
Led By Javier E. Oesterheld, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be age ≥ 3 and ≤ 30 years, and have had a histologic diagnosis of osteosarcoma, Ewing sarcoma, or rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma either at diagnosis or relapse
Must have experienced relapse after front-line therapy, or have had documented disease progression during front-line therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment to see if it can prevent tumors from growing or spreading in people with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or other soft tissue sarcomas. Researchers also want to see if the treatment is safe and tolerable.

Who is the study for?
This trial is for young people aged 3 to 30 with certain types of sarcoma, including osteosarcoma and Ewing sarcoma, that have come back or didn't respond to initial treatments. They must have measurable disease, be in good physical condition with a Karnofsky score ≥60, and not pregnant. Participants should not have had prior treatment with the study drugs or recent chemotherapy and agree to use contraception.Check my eligibility
What is being tested?
Researchers are testing if nab-Paclitaxel combined with Gemcitabine can stop tumor growth in patients whose sarcomas returned or resisted earlier treatments. The goal is also to see how long patients stay stable without their disease worsening after this treatment combination.See study design
What are the potential side effects?
Possible side effects include allergic reactions similar to those from other taxane drugs (like docetaxel), nerve damage (neuropathy) up to a mild level at most, as well as typical chemotherapy-related issues like fatigue, nausea, low blood counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 3 and 30 years old and have been diagnosed with a specific type of sarcoma.
Select...
My cancer returned or got worse during my first treatment.
Select...
My nerve damage symptoms are mild or not present.
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My cancer can be measured and tracked using specific criteria.
Select...
I can care for myself but may need occasional help.
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My cancer has returned or is not responding to treatment, and there is no cure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Response Rate
Secondary outcome measures
Occurrence of Study Treatment Related Adverse Events

Side effects data

From 2016 Phase 2 & 3 trial • 191 Patients • NCT01881230
55%
Fatigue
55%
Alopecia
43%
Nausea
42%
Diarrhoea
42%
Anaemia
40%
Neutropenia
30%
Vomiting
28%
Oedema peripheral
28%
Headache
25%
Decreased appetite
23%
Myalgia
23%
Peripheral sensory neuropathy
22%
Asthenia
22%
Arthralgia
22%
Constipation
20%
Pyrexia
20%
Cough
15%
Dysgeusia
13%
Rash
13%
Thrombocytopenia
13%
Hypokalaemia
13%
Hypertension
13%
Weight decreased
13%
Pain in extremity
13%
Insomnia
12%
Bone pain
12%
Dyspnoea
10%
Non-cardiac chest pain
10%
Upper respiratory tract infection
10%
Alanine aminotransferase increased
10%
Aspartate aminotransferase increased
10%
Dehydration
8%
Pleural effusion
8%
Abdominal pain upper
8%
Stomatitis
8%
Pruritus
7%
Oropharyngeal pain
7%
Pneumonia
7%
Cellulitis
7%
Neurotoxicity
7%
Paraesthesia
7%
Hot flush
7%
Fall
7%
Chills
7%
Folliculitis
7%
Leukopenia
7%
Hyperglycaemia
7%
Neuropathy peripheral
7%
Depression
7%
Erythema
7%
Abdominal pain
5%
Epistaxis
5%
Dry mouth
5%
Gastrooesophageal reflux disease
5%
Generalised oedema
5%
Influenza like illness
5%
Pain
5%
Sinusitis
5%
Urinary tract infection
5%
Spinal pain
5%
Anxiety
5%
Rash maculo-papular
5%
Rash pruritic
5%
Tachycardia
5%
Back pain
5%
Musculoskeletal chest pain
5%
Dizziness
5%
Rhinorrhoea
5%
Dyspepsia
5%
Drug hypersensitivity
5%
Neck pain
5%
Dry skin
5%
Vision blurred
3%
Bronchitis
3%
Hypoaesthesia
3%
Dyspnoea exertional
3%
Lymphoedema
2%
Breast cellulitis
2%
Haematemesis
2%
Haemorrhoidal haemorrhage
2%
Cardiac failure
2%
Palpitations
2%
Device related infection
2%
Metastases to meninges
2%
Respiratory tract congestion
2%
Lymphopenia
2%
Lacrimation increased
2%
Contusion
2%
Overdose
2%
Musculoskeletal pain
2%
Atrial fibrillation
2%
Sensory disturbance
2%
Influenza
2%
Hypomagnesaemia
2%
Ascites
2%
Endocarditis
2%
Respiratory failure
2%
Muscular weakness
2%
Device related sepsis
2%
Sepsis
2%
Confusional state
2%
Atelectasis
2%
Pneumothorax
2%
Pulmonary embolism
2%
Deep vein thrombosis
2%
Hepatic failure
2%
Nodular regenerative hyperplasia
2%
Febrile neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nab-Paclitaxel + Gemcitabine
Arm B: Nab-Paclitaxel + Carboplatin
Arm C: Gemcitabine + Carboplatin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination TherapyExperimental Treatment2 Interventions
Participants will receive nab-Paclitaxel and Gemcitabine on days 1, 8, and 15 of each 28 day cycle, for up to 12 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nab-Paclitaxel
2014
Completed Phase 3
~7680
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
540 Previous Clinical Trials
135,363 Total Patients Enrolled
National Pediatric Cancer FoundationOTHER
4 Previous Clinical Trials
138 Total Patients Enrolled
Javier E. Oesterheld, M.D.Principal InvestigatorCarolinas Medical Center, Levine Cancer Institute

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02945800 — Phase 2
Soft Tissue Sarcoma Research Study Groups: Combination Therapy
Soft Tissue Sarcoma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT02945800 — Phase 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02945800 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial offer enrollment opportunities at present?

"Affirmative. Clinicaltrials.gov data attests to the ongoing recruitment of participants for this trial, which was first introduced on October 25th 2016 and last updated November 17th 2022. 72 individuals need to be recruited from 16 sites in total."

Answered by AI

Are there any other investigations that have explored the efficacy of nab-Paclitaxel?

"The first study of nab-Paclitaxel commenced over two decades ago, at the City of Hope Comprehensive Cancer Center. Since then, 1857 trials have concluded and 1113 are actively recruiting participants - many located in Bronx, New york."

Answered by AI

What are the predominant indications for nab-Paclitaxel?

"Nab-Paclitaxel is commonly used to manage neoplasm metastasis and can also be employed in locally advanced non-small cell lung cancer, urinary bladder carcinoma, and metastatic bladder cancer."

Answered by AI

What is the aggregate amount of volunteers participating in this clinical study?

"Yes, according to information on clinicaltrials.gov this medical study is still recruiting participants. It was initially published on October 25th 2016 and the most recent update occurred November 17th 2022; 72 people are necessary for 16 sites across the United States of America."

Answered by AI

How many sites are presently managing this research project?

"The trial is in operation at various medical centres throughout the United States, including Montefiore Medical Center in Bronx, Connecticut Children's Medical Centre in Hartford, and Nemours Children's Clinic in Jacksonville. Additionally, there are 16 other sites hosting this study."

Answered by AI

Has nab-Paclitaxel been cleared by the FDA?

"Nab-Paclitaxel has been given a safety rating of 2 due to the current absence of clinical data confirming its efficacy, but there is evidence that it is not excessively dangerous."

Answered by AI

Do I fulfill the requirements to enter this experiment?

"This medical research is enrolling 72 individuals between the ages of three and thirty with a history of osteosarcoma, Ewing sarcoma, or rhabdomyosarcoma. Applicants must have had their cancer relapse after primary treatment; however, they should not have received prior gemcitabine nor nab-paclitaxel myelosuppressive chemotherapy within 3 weeks of protocol therapy on this study. Furthermore, no biologic (anti-neoplastic agent), monoclonal antibodies, radiotherapy or stem cell transplant/rescue may be active at the time that protocol therapy commences—"

Answered by AI

Is participation in this research endeavor limited to those under sixty years of age?

"The terms of eligibility for this trial state that the lowest age bracket to be admitted is 3 years old, while no one over 30 can participate."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What site did they apply to?
Vanderbilt - Ingram Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~6 spots leftby Dec 2024