Clinical trial · Interventional
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine in Treating Patients With Advanced Metastatic Solid Tumors
Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors
- 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 albumin-stabilized nanoparticle formulation and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with gemcitabine in treating patients with advanced 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 |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Dose Limiting Toxicity (DLT)
- timeFrame
- 21 days
- description
- Toxicity will be graded using the CTCAE version 3.0 and will be assessed on cycle one (21 days)
- measure
- Maximum Tolerated Dose(MTD)
- timeFrame
- 1 year
- description
- If greater than or equal to 2 of 6 patients (33%) experience a DLT, then that dose level will be considered to have excessive toxicity and will = MTD
Secondary outcomes (1)
- measure
- Radiographic Response to Treatment
- timeFrame
- every 42 days
- description
- Radiographic response will be measured and evaluated using RECIST criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumors * Advanced metastatic disease * Measurable or evaluable disease * Must meet 1 of the following criteria: * Failed prior standard therapy * Not a candidate for standard therapy * Has a disease for which there is no defined standard therapy * No symptomatic brain metastases PATIENT CHARACTERISTICS: * ECOG functional status 0-2 * Life expectancy ≥ 8 weeks * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * Bilirubin normal * Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min * AST and ALT ≤ 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * No prior anaphylactic reaction or severe allergic reaction to paclitaxel, docetaxel, or gemcitabine hydrochloride * No active infectious process that will require treatment with antibiotics for \> 4 weeks * No uncontrolled congestive heart failure * No symptomatic coronary artery disease or heart block * No myocardial infarction within the past 3 months * No peripheral neuropathy ≥ grade 2 from any cause PRIOR CONCURRENT THERAPY: * More than 3 weeks since prior chemotherapy, radiotherapy, or any other treatment * No prior radiotherapy to \> 25% of bone marrow * No prior nitrosoureas * No more than 6 prior courses of alkylating agents * No more than 2 prior courses of mitomycin C * No more than 3 prior courses of cytotoxic therapy for metastatic disease * No concurrent filgrastim (G-CSF), pegfilgrastim, or sargramostim (GM-CSF) during study course 1
References
Publications (0)
Data not yet available