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Taxane
Triple Drug Therapy for Osteosarcoma
Phase 1 & 2
Waitlist Available
Led By John A Livingston
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of =< 2. Use Karnofsky for patients > 16 years old and Lansky for patients =< 16
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN for age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a combination of three drugs to treat osteosarcoma.
Who is the study for?
This trial is for people with osteosarcoma that has returned or isn't responding to treatment. They must have a certain level of kidney function, measurable disease, and be able to perform daily activities with some limitations. Participants need available tumor tissue for research and should not have had previous treatments with the drugs being tested in this study.Check my eligibility
What is being tested?
The trial is testing the combination of three chemotherapy drugs: gemcitabine, docetaxel, and hydroxychloroquine. It aims to find the safest doses and see how well they work together against recurrent or stubborn osteosarcoma by stopping cancer cells from growing or spreading.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, hair loss (from docetaxel), low blood counts leading to infection risk (from gemcitabine), and vision changes like retinopathy (from hydroxychloroquine). Each drug can also cause unique side effects related to its mechanism on cancer cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself and am up more than 50% of my waking hours.
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My liver enzymes are within normal limits for my age.
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My kidney function, measured by creatinine clearance or GFR, is good.
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My bilirubin levels are within normal range for my age.
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My diagnosis is osteosarcoma.
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My cancer did not respond or has returned after treatment with specific chemotherapy drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control rate (Phase II)
Maximum tolerated dose of hydroxychloroquine (Phase I)
Secondary outcome measures
Event free survival
Overall response (complete response [CR] or partial response [PR] versus not CR or PR)
Side effects data
From 2016 Phase 3 trial • 217 Patients • NCT0205725013%
Upper respiratory tract infection
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Anaemia
1%
Lumbar spinal stenosis
1%
Leukopenia
1%
Coronary artery occlusion
1%
Wolff-Parkinson-White syndrome
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarilumab 150 mg by PFS (Extension Phase)
Sarilumab 150 mg by AID (AID Assessment Phase)
Sarilumab 150 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by AID (AID Assessment Phase)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (hydroxychloroquine, gemcitabine, docetaxel)Experimental Treatment3 Interventions
Participants receive hydroxychloroquine PO QD or BID on days 1-21, gemcitabine IV over 90 minutes on days 1 and 8, and docetaxel IV over 1 hours on day 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
FDA approved
Gemcitabine
FDA approved
Hydroxychloroquine
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,477 Total Patients Enrolled
14 Trials studying Osteosarcoma
476 Patients Enrolled for Osteosarcoma
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,340 Total Patients Enrolled
103 Trials studying Osteosarcoma
16,543 Patients Enrolled for Osteosarcoma
John A LivingstonPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Osteosarcoma
40 Patients Enrolled for Osteosarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself and am up more than 50% of my waking hours.My liver enzymes are within normal limits for my age.My kidney function, measured by creatinine clearance or GFR, is good.My blood clotting tests are within normal limits, except if I'm on blood thinners for clots.I haven't had cancer treatment in the last 21 days, or targeted therapy in the last 28 days.I do not have acute hepatitis B or C, but if chronic, it is stable and not a safety risk.I have an eye condition affecting my macula or retina.I have been treated with gemcitabine or docetaxel before.I agree to use effective birth control during and after the study.My cancer may or may not be removable by surgery, but I am willing to wait 4 months for surgery to see if the treatment works.I can provide a sample of my tumor or undergo a biopsy.I haven't had a heart attack in the last 6 months and my heart condition is stable.I have a serious gut condition that could affect how my body absorbs medication.My side effects from previous cancer treatments are mild or have been stable for more than 4 weeks.My bilirubin levels are within normal range for my age.I have not had major surgery in the last 28 days.All supplements I've taken in the last 30 days are approved by the study leader.I can attend all required study visits.I have not needed IV antibiotics for an infection in the last 2 weeks.My diagnosis is osteosarcoma.I am not breastfeeding or planning to get pregnant during the study.I have no other cancers except for treated skin cancer or cancers that were cured over 2 years ago.I can understand and follow the study's requirements.My cancer did not respond or has returned after treatment with specific chemotherapy drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (hydroxychloroquine, gemcitabine, docetaxel)
Awards:
This trial has 3 awards, including:- 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.
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.
Under what circumstances is Hydroxychloroquine typically prescribed?
"Hydroxychloroquine is primarily utilized as a therapeutic agent for malignant esophageal neoplasms, however it can also assist people with malaria, rheumatoid arthritis and those going through adjuvant anthracycline-containing treatment."
Answered by AI
Has Hydroxychloroquine been utilized in any other research experiments?
"As of now, there are 786 active studies involving Hydroxychloroquine with 253 trials in the third phase. Of these trial sites, most are situated in Shanghai; however, 42865 other locations around the world have conducted research on this drug's efficacy."
Answered by AI
What is the current intake capacity of this research endeavor?
"Affirmative, clinicaltrials.gov displays evidence that this trial is seeking applicants from the public. It was initially announced on January 28th 2019 and its information recently updated on September 13th 2022. This study requires 31 people to be recruited at a single site."
Answered by AI
Are recruitment efforts underway for this clinical experiment?
"Affirmative. Clinicaltrials.gov reveals that, as of 9/13/2022, this research effort is still actively seeking volunteers and has been since its inception on 1/28/2019. 31 patients are required to be recruited from a single medical site."
Answered by AI
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