Clinical trial · Interventional
Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Randomized, Crossover, Pharmacokinetic Study Of Paclitaxel (Taxol) And ABI-007 (A Cremophor EL-Free, Protein Stabilized, Nanoparticle Paclitaxel) In Patients With Advanced Solid Tumors
NCT00095914CI-TRIAL-00006473completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 paclitaxel and ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with ABI-007 may kill more tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with ABI-007 in treating patients who have locally advanced or metastatic solid tumors.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel | Drug | Paclitaxel | ALIAS |
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | Nab-paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant solid tumor * Considered incurable * Locally advanced or metastatic disease * Likely to be responsive to taxane-based therapy * Patients who are refractory to prior paclitaxel are ineligible * No symptomatic or untreated brain metastasis or carcinomatous meningitis * No patients who are unable to remain free of corticosteroid therapy for \> 4 weeks due to CNS disease * No previously untreated locally advanced breast cancer * No hematologic malignancy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin normal * ALT and AST ≤ 1.5 times upper limit of normal Renal * Creatinine normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * LVEF ≥ 40% * No clinical signs or symptoms of heart failure * No symptomatic congestive heart failure * No unstable angina pectoris Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study participation * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to paclitaxel (e.g., docetaxel, Cremophor\^® EL \[CrEL\], polysorbate 80 \[Tween 80\], or CrEL-containing medications \[e.g., cyclosporine\]) * No history of seizure disorder requiring anticonvulsant therapy * No active serious infection * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy * No concurrent filgrastim (G-CSF) during courses 1 and 2 Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No other concurrent chemotherapy Endocrine therapy * See Disease Characteristics * At least 2 weeks since prior hormonal therapy * Concurrent luteinizing hormone-releasing hormone agonists for prostate cancer allowed Radiotherapy * At least 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * More than 2 weeks since prior drugs, herbal preparations, or dietary supplements known to influence CYP3A4 (e.g., phenytoin, rifampin, Hypericum perforatum \[St. John's wort\], garlic supplements, or grapefruit juice) and/or CYP2C8 * No concurrent substances known or likely to interfere with the pharmacokinetics of paclitaxel (e.g., verapamil or cyclosporine) * No other concurrent investigational agents * No other concurrent anticancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.