NCT03598595 is a Phase 1, PHASE2 clinical trial of Docetaxel in Recurrent Osteosarcoma, sponsored by M.D. Anderson Cancer Center.

Who is sponsoring NCT03598595?

NCT03598595 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT03598595?

Interventions in NCT03598595: Docetaxel, Gemcitabine, Hydroxychloroquine.

What condition does NCT03598595 study?

NCT03598595 studies Recurrent Osteosarcoma, Refractory Osteosarcoma.

Is NCT03598595 still recruiting?

NCT03598595 is currently active, enrolled. Last updated 4 February 2026.

Last reviewed 2026-02-04 · How we verify

NCT03598595

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Gemcitabine, Docetaxel, and Hydroxychloroquine in Treating Participants With Recurrent or Refractory Osteosarcoma

Active, enrolled Phase 1, PHASE2 Last updated 4 February 2026

What this trial tests

Phase 1, PHASE2 trial testing Docetaxel in Recurrent Osteosarcoma in 31 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

28 January 2019

Primary endpoint
31 May 2026

31 May 2026

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	28 January 2019
Primary completion	31 May 2026
Estimated completion	31 May 2026
Sites	1 location across United States

Drugs / interventions tested

Docetaxel (Docetaxel) — full drug profile →
Gemcitabine (gemcitabine) — full drug profile →
Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →

Conditions studied

Recurrent Osteosarcoma — all drugs for Recurrent Osteosarcoma →
Refractory Osteosarcoma — all drugs for Refractory Osteosarcoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

12 and older, any sex, with Recurrent Osteosarcoma or Refractory Osteosarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I/II trial studies the side effects and best dose of hydroxychloroquine and how well it works when given together with gemcitabine and docetaxel in treating participants with osteosarcoma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as gemcitabine, docetaxel, and hydroxychloroquine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The Dual Role of Autophagy in Cancer Development and a Therapeutic Strategy for Cancer by Targeting Autophagy.
Yun CW, Jeon J, Go G, Lee JH, et al · · 2020 · cited 147× · PMID 33375363 · DOI 10.3390/ijms22010179
Chloroquine against malaria, cancers and viral diseases.
Zhou W, Wang H, Yang Y, Chen ZS, et al · · 2020 · cited 85× · PMID 32947043 · DOI 10.1016/j.drudis.2020.09.010
Pathogenesis and Current Treatment of Osteosarcoma: Perspectives for Future Therapies.
Rathore R, Van Tine BA. · · 2021 · cited 81× · PMID 33809018 · DOI 10.3390/jcm10061182
Regulation of Apoptosis by Autophagy to Enhance Cancer Therapy.
Tompkins KD, Thorburn A. · · 2019 · cited 51× · PMID 31866785
Insight Into the Role of Autophagy in Osteosarcoma and Its Therapeutic Implication.
Niu J, Yan T, Guo W, Wang W, et al · · 2019 · cited 45× · PMID 31803616 · DOI 10.3389/fonc.2019.01232
Autophagy Takes Center Stage as a Possible Cancer Hallmark.
Alvarez-Meythaler JG, Garcia-Mayea Y, Mir C, Kondoh H, et al · · 2020 · cited 40× · PMID 33194736 · DOI 10.3389/fonc.2020.586069
Autophagy as a mechanism for anti-angiogenic therapy resistance.
Chandra A, Rick J, Yagnik G, Aghi MK. · · 2020 · cited 40× · PMID 31472232 · DOI 10.1016/j.semcancer.2019.08.031
Autophagy Regulation on Cancer Stem Cell Maintenance, Metastasis, and Therapy Resistance.
Wang X, Lee J, Xie C. · · 2022 · cited 38× · PMID 35053542 · DOI 10.3390/cancers14020381

Verify or expand the search:

Other trials of Docetaxel

Trials testing the same drug.

NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors · Phase 1 · not yet recruiting
NCT07361484 — Docetaxel Plus Plinabulin vs Docetaxel Plus Placebo in Advanced/Metastatic Non-Squamous NSCLC After PD-1/PD-L1 Therapy a · Phase 3 · not yet recruiting
NCT07415031 — A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies · Phase 2 · not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · recruiting
NCT07487896 — A Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esopha · Phase 3 · not yet recruiting

Other recruiting trials for Recurrent Osteosarcoma

Currently open trials in the same condition.

NCT07227571 — Genetically Engineered Cells (FH-FOLR1 ST CAR T Cells) for the Treatment of Advanced Refractory or Recurrent/Progressive · Phase 1 · recruiting
NCT05019703 — Atezolizumab and Cabozantinib for the Treatment of Adolescents and Young Adults With Recurrent or Metastatic Osteosarcom · Phase 2 · recruiting
NCT04851119 — Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors · Phase 1, PHASE2 · recruiting
NCT04901702 — Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma · Phase 1, PHASE2 · recruiting
NCT04320888 — Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene A · Phase 2 · active not recruiting

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03598595 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 4 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03598595.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing