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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

Must not have

Patients with pre-existing maculopathy or retinopathy of the eye

Patients who have previously received gemcitabine or docetaxel

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an eye condition affecting my macula or retina.

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I have been treated with gemcitabine or docetaxel before.

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I haven't had a heart attack in the last 6 months and my heart condition is stable.

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I have not had major surgery in the last 28 days.

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I am not breastfeeding or planning to get pregnant during the study.

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I can understand and follow the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 3 trial • 217 Patients • NCT02057250

13%

Upper respiratory tract infection

Neutropenia

Sinusitis

Alanine aminotransferase increased

Urinary tract infection

Injection site erythema

Accidental overdose

Bronchitis

Injection site pruritus

Thrombocytopenia

Nasopharyngitis

Contusion

Arthralgia

Wolff-Parkinson-White syndrome

Coronary artery occlusion

Anaemia

Leukopenia

Lumbar spinal stenosis

Transient ischaemic attack

Vertebrobasilar insufficiency

Chronic obstructive pulmonary disease

Small intestinal obstruction

Nephrolithiasis

Cataract

Thrombophlebitis superficial

Vomiting

Endometrial hyperplasia

Traumatic arthritis

Hypertension

Pneumonia

Pancreatic carcinoma metastatic

Osteoarthritis

Rheumatoid lung

Pharyngitis

Femoral neck fracture

100%

80%

60%

40%

20%

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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

0 / 12Eligibility criteria met