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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00103389
First received: February 7, 2005
Last updated: September 22, 2008
Last verified: March 2006
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: PI-88
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months [ Designated as safety issue: No ]
  • Non-progression rate as measured by RECIST v2.0 at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6 [ Designated as safety issue: No ]
  • Response rate as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6 [ Designated as safety issue: No ]
  • Quality of life as measured by Lung Cancer Symptom Scale (LCSS) every month [ Designated as safety issue: No ]
  • Overall survival as measured by RECIST v2.0 at death [ Designated as safety issue: No ]

Study Start Date: February 2004
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103389

Locations
Australia, New South Wales
Sydney Heamatology and Oncology Clinics
Hornsby, New South Wales, Australia, 2077
Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Nambour General Hospital
Nambour, Queensland, Australia, 4560
Mater Medical Centre
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Murray Valley Private Hospital and Cancer Treatment Centre
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Sir Charles Gairdner Hospital - Perth
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
Progen Pharmaceuticals
Investigators
Study Chair: Nick Pavlakis, MD Royal North Shore Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00103389     History of Changes
Other Study ID Numbers: CDR0000409568, PROGEN-PR88202, AUS-RNSH-0309-183M
Study First Received: February 7, 2005
Last Updated: September 22, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014