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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Nick Pavlakis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Royal North Shore Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000409568

NCT ID:

NCT00103389

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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