Docetaxel With or Without PI-88 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00103389
• Other study ID #: PROGEN-PR88202
• Secondary ID: CDR0000409568AUS
• Status: Completed
• Phase: Phase 2
• Start date: February 2004
• Est. completion date: May 2007

Study information

• Verified date: June 2022
• Source: Cellxpert Biotechnology Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PI-88 may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. It may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving docetaxel together with PI-88 may kill more tumor cells. It is not yet known whether giving docetaxel together with PI-88 is more effective than docetaxel alone in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying docetaxel and PI-88 to see how well they work when given together compared to docetaxel alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Description:

OBJECTIVES:

Primary

• Compare the safety and efficacy of docetaxel with vs without PI-88 in patients with stage IIIB or IV non-small cell lung cancer.

Secondary

• Determine the efficacy markers of docetaxel and PI-88 in these patients.

• Determine the safety and potential efficacy of PI-88 alone as maintenance therapy in patients whose disease has been controlled with docetaxel and PI-88 combination therapy.

• Determine the safety and potential efficacy of PI-88 alone as third-line therapy in these patients.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15.

• Arm II: Patients receive docetaxel as in arm I. Patients also receive PI-88 subcutaneously once daily on days 1-4, 8-11, and 15-18.

In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients in arm II with stable or responding disease after 6 courses may continue to receive PI-88 alone as maintenance therapy. Patients in arm I with progressive disease or unacceptable toxicity before the completion of 6 courses may receive PI-88 alone as third-line therapy.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of non-small cell lung cancer

• Stage IIIB or IV disease

• Eligible for second-line docetaxel

• Disease progression during or after completion of prior first-line therapy comprising radiotherapy and/or platinum-based chemotherapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 2 months

Hematopoietic

• Neutrophil count > 1,500/mm^3

• Platelet count > 100,000/mm^3

• WBC > 3,000/mm^3

• No history of thrombotic thrombocytopenic purpura or other platelet disease

Hepatic

• Bilirubin normal

• ALT and AST = 2.5 times upper limit of normal (ULN) (1.5 times ULN if alkaline phosphatase > 2.5 times ULN)

• Alkaline phosphatase = 5 times ULN (unless bone metastases are present)

• PT < 1.5 times ULN

• Activated PTT normal

Renal

• Creatinine clearance or glomerular filtration rate > 50mL/min

Cardiovascular

• None of the following within the past 3 months:

• Myocardial infarction

• Stroke

• Congestive heart failure

Immunologic

• No history of immune-mediated thrombocytopenia

• No evidence of anti-heparin antibodies

• No history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents, especially heparin

• No history of allergy to polysorbate 80

• No uncontrolled or serious infection within the past 4 weeks

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• No prior docetaxel

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• More than 3 months since prior radiotherapy to > 30% of marrow-bearing bone

• Concurrent local palliative radiotherapy allowed

Surgery

• More than 4 weeks since prior major surgery

Other

• More than 4 weeks since prior antineoplastic therapy

• More than 2 weeks since prior and no concurrent heparin or low-molecular weight heparin

• More than 4 weeks since prior investigational therapy

• No concurrent aspirin or aspirin-containing medications except low-dose aspirin (= 100 mg/day)

• No concurrent nonsteroidal anti-inflammatory drugs except cyclooxygenase-2 inhibitors

• No concurrent warfarin or warfarin-containing medications except low-dose warfarin (= 1 mg/day)

• No concurrent antiplatelet drugs, including any of the following:

• Abciximab

• Clopidogrel

• Dipyridamole

• Ticlopidine

• Tirofiban

• No concurrent drugs that may inhibit docetaxel metabolism, including any of the following:

• Cyclosporine

• Terfenadine

• Ketoconazole

• Erythromycin

• Troleandomycin

• No other concurrent investigational drugs

• No other concurrent antineoplastic therapy

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• PI-88
PI-88+docetaxel
• docetaxel
docetaxel only

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Prince Charles Hospital	Chermside	Queensland
Australia	Sydney Heamatology and Oncology Clinics	Hornsby	New South Wales
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Nambour General Hospital	Nambour	Queensland
Australia	Sir Charles Gairdner Hospital - Perth	Perth	Western Australia
Australia	Institute of Oncology at Prince of Wales Hospital	Randwick	New South Wales
Australia	Mater Medical Centre	South Brisbane	Queensland
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
Australia	Sydney Cancer Centre at Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	Newcastle Mater Misericordiae Hospital	Waratah	New South Wales
Australia	Murray Valley Private Hospital and Cancer Treatment Centre	Wodonga	Victoria
Australia	Queen Elizabeth Hospital	Woodville	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
Cellxpert Biotechnology Corp.	Medigen Biotechnology Corporation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months
Primary	Non-progression rate as measured by RECIST v2.0 at 6 months
Secondary	Time to progression as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
Secondary	Response rate as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
Secondary	Quality of life as measured by Lung Cancer Symptom Scale (LCSS) every month
Secondary	Overall survival as measured by RECIST v2.0 at death