Docetaxel Lipid Microsphere (DT-LM) for Injection in Chemotherapy Patients

NCT01611961 | Unknown Phase 1 DMC

• 1 other identifier: SYPHU-DT-LM-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Docetaxel Lipid Microsphere (DT-LM) is a novel proprietary delivery system of docetaxel developed by Shenyang Pharmaceutical University. In this Phase I study, the DT-LM was evaluated for the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) in patients with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects of DT-LM compared to commerical docetaxel.

Conditions

Advanced Cancer

Keywords

Docetaxel; Lipid Microsphere; Neoplasms; Antineoplastic Agents; Pharmacologic Actions; Therapeutic Uses

Outcome Measures

Primary Outcomes (1)

• The safety and tolerability

  This Phase I, open-label, control,dose-escalation study was designed to determine the maximum tolerated dose (MTD) of DT-LM in patients with advanced cancer. DT-LM was administered by intravenous infusion, over 1 hour, once every 21 days until occurrence of disease progression or toxicity requiring early treatment discontinuation. Dose escalation was not done until the safety and tolerability at a given dose level has been confirmed.

  one year

Secondary Outcomes (2)

• Assessment of pharmacokinetics of DT-LM and Taxotere: AUC and Cmax

  one year

• Objective tumour response according to RECIST

  one year

Study Arms (2)

DT-LM

EXPERIMENTAL

Docetaxel Lipid Microsphere (DT-LM)

Drug: DT-LM

Taxotere

ACTIVE COMPARATOR

Commerical Product

Drug: docetaxel

Interventions

DT-LM DRUG

Intravenous infusion, Upto 6 dose levels have been studied i.e. 45, 60, 75, 90 105,and 120 mg/m2, Every 3 weeks.

Also known as: Docetaxel Lipid Microsphere

DT-LM

docetaxel DRUG

Intravenous infusion, 3 dose levels：60, 75, and 90 mg/m2, Every 3 weeks

Also known as: Taxotere

Taxotere

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 and \< 65, with ECOG performance status 0-1,and Life expectancy of more than 3 months.
• Have advanced (local and/or metastatic) histologically documented cancer considered unresponsive to available conventional modalities or treatments.
• Have recovered from acute toxicities of prior treatment:
• weeks must have elapsed since receiving any investigational agent.
• weeks must have elapsed since receiving any radiotherapy, or treatment with cytotoxic or biologic agents (≥6 weeks for mitomycin or nitrosoureas).
• weeks must have elapsed since any prior surgery.
• Be in adequate condition as evidenced by the following clinical laboratory values:
• Absolute neutrophil count (ANC) ≥1,500/mm3.
• Platelets ≥ 80,000/mm3.
• Hemoglobin ≥ 9.0 g/dL.
• WBC ≥ 4,000/mm3.
• Total bilirubin ≤ 2.5 x institutional upper limit normal (ULN).
• Transaminases AST (SGOT) and ALT (SGPT) ≤ 1.5 times ULN or ≤ 5 times ULN (liver metastasis).
• Serum creatinine ≤ 1.2 times ULN, blood urea nitrogen≤ 1.2 times ULN.
• both female and male patients must use adequate methods of contraception.

You may not qualify if:

• Intolerance to any antineoplastic agents belonging to the taxoid family.
• having failed a docetaxel-containing regimen or Having known non-controllable hypersensitivity to docetaxel or lipid microsphere.
• Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease).
• Unstable or uncontrolled cardiac disease or hypertension.
• With other serious internal diseases, uncontrolled infection or uncontrolled diabetes.
• With Symptomatic brain metastasis not controlled.
• Having pre-existing clinically significant neuropathy (NCI CTCAE Grade ≥ 2 neuromotor or Grade ≥ 2 neurosensory) except for abnormalities due to cancer.
• Currently receiving any other standard or investigational treatment for cancer or any other investigational agent for any indication.
• Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
• Female patients who are pregnant or breast-feeding.
• Unwilling or unable to follow protocol requirements.
• With history of serious allergic or allergy.
• Not fit for the clinical trial judged by the investigator.

Sponsors & Collaborators

• Shenyang Pharmaceutical University: lead

Study Sites (1)

Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Xing Tang, Ph.D

  Shenyang Pharmaceutical University

  STUDY DIRECTOR

Central Study Contacts

Yuankai Shi

CONTACT

86-10-87788121

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the Director of Oncology Department

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 5, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

CN (1)