Clinical trial · Interventional
Docetaxel With or Without PI-88 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| PI-88 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- docetaxel
- description
- treated with docetaxel alone
- interventionNames
- Drug: docetaxel
- type
- EXPERIMENTAL
- label
- PI-88+docetaxel
- description
- treated with docetaxel and PI-88
- interventionNames
- Drug: PI-88
- Drug: docetaxel
Primary outcomes (2)
- measure
- Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available