Clinical trial · Interventional
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Metastatic Solid Tumors
A Phase I Trial of Carboplatin and Abraxane 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 carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle formulation together with carboplatin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects, the best way to give, and the best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin in treating patients with 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 |
|---|---|---|---|
| Abraxane | Drug | Paclitaxel | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Weekly Arm
- description
- Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle
- interventionNames
- Drug: Carboplatin
- Drug: Abraxane
- type
- EXPERIMENTAL
- label
- Every 3 week Arm
- description
- Carboplatin day 1, abraxane day 1, every 21 day cycle
- interventionNames
- Drug: Carboplatin
- Drug: Abraxane
- type
- EXPERIMENTAL
- label
- Arm C
- description
- Carboplatin day 1, abraxane day 1, 8 every 21 day cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically or cytologically confirmed solid tumor * Advanced or metastatic disease * Measurable or evaluable disease * Must meet 1 of the following criteria: * Failed a standard therapy * Not a candidate for standard therapy * Have a disease for which there is no defined standard therapy Exclusion criteria: * Symptomatic brain metastases PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG performance status 0-2 * Life expectancy ≥ 8 weeks * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 8.0 g/dL * Total bilirubin normal * Serum creatinine normal OR creatinine clearance ≥ 60 mL/min * AST and ALT ≤ 2.5 x upper limit of normal * Negative pregnancy test Exclusion criteria: * Pregnant or lactating * Prior anaphylactic reaction or severe allergic reaction to paclitaxel and/or docetaxel * Active infection that requires treatment with antibiotics for \> 4 weeks * Uncontrolled congestive heart failure * Symptomatic coronary artery disease or heart block * Myocardial infarction within the past 3 months * Peripheral neuropathy ≥ grade 2 from any cause PRIOR CONCURRENT THERAPY: * No prior chemotherapy, radiotherapy, or any other therapy for malignancy within the past 3 weeks * No concurrent filgrastim, pegfilgrastim, or sargramostim during the first course of therapy
References
Publications (0)
Data not yet available