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

NCT00103389 | Completed Phase 2

• 3 other identifiers: PROGEN-PR88202CDR0000409568AUS-RNSH-0309-183M
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months

• Non-progression rate as measured by RECIST v2.0 at 6 months

Secondary Outcomes (4)

• Time to progression as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6

• Response rate as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6

• Quality of life as measured by Lung Cancer Symptom Scale (LCSS) every month

• Overall survival as measured by RECIST v2.0 at death

Study Arms (2)

docetaxel

ACTIVE COMPARATOR

treated with docetaxel alone

Drug: docetaxel

PI-88+docetaxel

EXPERIMENTAL

treated with docetaxel and PI-88

Drug: PI-88; Drug: docetaxel

Interventions

PI-88 DRUG

PI-88+docetaxel

PI-88+docetaxel

docetaxel DRUG

docetaxel only

PI-88+docetaxel; docetaxel

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cellxpert Biotechnology Corp.: lead
• Medigen Biotechnology Corporation: collaborator

Study Sites (13)

Sydney Heamatology and Oncology Clinics

Hornsby, New South Wales, 2077, Australia

Location

Institute of Oncology at Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Newcastle Mater Misericordiae Hospital

Waratah, New South Wales, 2298, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Nambour General Hospital

Nambour, Queensland, 4560, Australia

Location

Mater Medical Centre

South Brisbane, Queensland, 4101, Australia

Location

Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Murray Valley Private Hospital and Cancer Treatment Centre

Wodonga, Victoria, 3690, Australia

Location

Sir Charles Gairdner Hospital - Perth

Perth, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

phosphomannopentaose sulfate; Docetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Nick Pavlakis, MD

  Royal North Shore Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2005
• First Posted: February 8, 2005
• Study Start: February 1, 2004
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (13)