Table 6.
Clinical trials of nanocarriers for cancer therapy
| Study Title | Types of Cancer | Interventions | Phase | Outcome | Pateints | Sex | NCT Number |
|---|---|---|---|---|---|---|---|
| Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Gemcitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer | Breast Cancer | Biological: bevacizumab, Drug: gemcitabine hydrochloride, Drug: paclitaxel albumin-stabilized nanoparticle formulation | Phase 2 | 6-month Progression-free Survival (PFS) Rate, Overall Survival Time, PFS Time | 50 | All | NCT00662129 |
| ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer | Breast Cancer | Drug: Gemcitabine, Drug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound) | Phase 2 | Proportion of Patients With Confirmed Responses, Progression-free Survival, Overall Survival, and Adverse Event | 50 | Female | NCT00110084 |
| Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer | Breast Cancer | Drug: nab paclitaxel, Drug: Cyclophosphamide, Drug: Trastuzumab | Phase 2 | Number of Participants Who Remained Alive Without Evidence of Recurrence as a Measure of Tolerability of Adjuvant Nab Paclitaxel, Disease-free Survival, Overall Survival | 63 | All | NCT00629499 |
| S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer | Breast Cancer | Biological: bevacizumab, Biological: pegfilgrastim, Drug: cyclophosphamide, and 2 more… | Phase 2 | Number of Patients With Pathological Complete Response Rate, Overall Survival, Event-free Survival, and Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug | 215 | Female | NCT00856492 |
| Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer | Breast Cancer | Biological: bevacizumab, Drug: Carboplatin, Drug: ABI-007 | Phase 2 | Progression-free Survival, Response Rate at End of Treatment, Overall Survival | 32 | All | NCT00654836 |
| Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery | Lung Cancer | Drug: carboplatin, Drug: erlotinib hydrochloride, Drug: paclitaxel albumin-stabilized nanoparticle formulation, Radiation: radiation therapy | Phase 2 | Overall Survival at 12 Months, Response Rate, Progression-free Survival | 78 | All | NCT00553462 |
| Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer | Lung Cancer | Drug: carboplatin, Drug: paclitaxel albumin-stabilized nanoparticle formulation, Genetic: protein expression analysis, and 3 more… | Phase 2 | Overall Response Rate Defined as Complete or Partial Response as Assessed by RECIST Version 1.0 Criteria, Progression Free Survival, Overall Survival, and Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0 | 63 | All | NCT00729612 |
| Phase II NCT (Neoadjuvant Chemotherapy) w/ Weekly Abraxane in Combination With Carboplatin & Bevacizumab in Breast Cancer | Breast Cancer | Drug: bevacizumab, Drug: carboplatin, Drug: nab-paclitaxel, and 2 more… | Phase 2 | Number of Patients With Pathologic Complete Response (pCR), Side Effects of Weekly Nab-paclitaxel, Carboplatin and Bevacizumab, Evaluation of Dynamic Contrast-enhanced Magnetic Resonance Imaging in Assessing pCR at Baseline and After 2 Cycles of Neoadjuvant Therapy, and Overall Expression of LZTS1 Before and After Neoadjuvant Therapy as Assessed by Immunohistochemistry | 33 | Female | NCT00675259 |
| Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer | Other: Laboratory Biomarker Analysis, Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation | Phase 2 | Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria, Overall Percentage of Patients Experiencing Toxicity Within a Clinically Significant Category Defined as Neutropenia, Neutropenic Fever, or Neuropathy, Overall Survival | 26 | All | NCT01620190 |
| Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy | Pancreatic Cancer | Drug: Abraxane | Phase 2 | Overall Survival Rate at 6 Months, Number of Participants Showing Complete or Partial Response, Number of Participants Showing Stable Disease | 20 | All | NCT00691054 |
| Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer | Non-muscle Invasive Bladder Cancer (NMIBC) | Drug: ABI-009, Drug: Gemcitabine | Phase 1, Phase 2 | Phase 1: Dose Limiting Toxicities (DLT) Following Intravesical Administration of ABI-009, Phase 2: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009 and Gemcitabine, Phase 1: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009 | 21 | All | NCT02009332 |
| Doxorubicin Hydrochloride, Cyclophosphamide, and Filgrastim Followed By Paclitaxel Albumin-Stabilized Nanoparticle Formulation With or Without Trastuzumab in Treating Patients With Breast Cancer Previously Treated With Surgery | Estrogen Receptor-positive Breast Cancer, HER2-positive Breast Cancer, and 6 more… | Drug: doxorubicin hydrochloride, Drug: cyclophosphamide, Biological: filgrastim, and 4 more… | Phase 2 | Disease-free Survival Following a Dose-intensive Weekly Regimen of Adriamycin + Oral Cyclophosphamide Augmented With G-CSF Support Followed by Abraxane and Herceptin, Delivered Dose Intensity of the Regimen, Toxicity Associated With This Regimen | 60 | Female | NCT00407888 |
| Phase II Study With Abraxane, Bevacizumab and Carboplatin in Triple Negative Metastatic Breast Cancer | Breast Cancer | Drug: Abraxane, Drug: Bevacizumab, Drug: Carboplatin | Phase 2 | Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III "Triple Negative" Metastatic Breast Cancer, Median Proportion Progression-free as Estimated by Kaplan–Meier Methods, To Evaluate Sequential Plasma Samples for Presence of Selected Angiogenic Markers | 41 | Female | NCT00479674 |
| Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer | Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer, and 3 more… | Drug: paclitaxel albumin-stabilized nanoparticle formulation, Biological: bevacizumab, Drug: erlotinib hydrochloride | Phase 2 | Progression-free Survival (PFS), Overall Survival, Percentage of Participants With Response | 59 | Female | NCT00733408 |
| Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy | Brenner Tumor, Fallopian Tube Cancer, Ovarian Clear Cell Cystadenocarcinoma, and 9 more… | Biological: sargramostim, Drug: paclitaxel albumin-stabilized nanoparticle formulation, Other: laboratory biomarker analysis, and 2 more… | Phase 2 | Time to Progression, Response Rate, Correlation Between Circulating Monocytes and Time to Progression | 21 | All | NCT00466960 |
| Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine Hydrochloride With or Without WEE1 Inhibitor AZD1775 in Treating Patients With Previously Untreated Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery | Metastatic Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v6 and v7, Stage IV Pancreatic Cancer AJCC v6 and v7, and 1 more… | Drug: AZD1775, Drug: Gemcitabine, Drug: Nab-paclitaxel | Phase 1, Phase 2 | Number of Participants With Dose Limiting Toxicities (DLT), To Determine the Pharmacokinetics of AZD1775 in Combination With Nab-paclitaxel and Gemcitabine, Progression-free Survival | 8 | All | NCT02194829 |
| Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer | Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, and 6 more… | Biological: Bevacizumab, Drug: Ixabepilone, Other: Laboratory Biomarker Analysis, and 3 more… | Phase 3 | Progression Free Survival, Objective Tumor Response Rate, Time to Treatment Failure | 799 | All | NCT00785291 |
| Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer | Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma | Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation | Phase 2 | Tumor Response, Frequency and Severity of Observed Adverse Effects, Progression-free Survival, Overall Survival | 51 | Female | NCT00499252 |
| Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer | Breast Cancer | Drug: Albumin-bound paclitaxel, Drug: Carboplatin, Drug: Herceptin® | Phase 2 | Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response, Percentage of Participants With a Total Response, Time to Disease Progression | 32 | Female | NCT00093145 |
| A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer | Advanced or Metastatic Solid Tumors, Advanced or Metastatic Breast Cancer | Drug: Azacitidine (Vidaza), Drug: Nab-paclitaxel (Abraxane) | Phase 1, Phase 2 | Phase I: Percentage of Participants Responding to Treatment, Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria, Number of Participants With ER + Status, Progression-free Survival | 30 | All | NCT00748553 |
| A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer | Non-Small Cell Lung Cancer | Drug: CRLX101, Other: Best Supportive Care | Phase 2 | To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only, Assess Objective Response Rate (ORR) of CRLX101 + BSC Compared to BSC Only | 157 | All | NCT01380769 |
| Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer | Head and Neck Cancer | Biological: Cetuximab, Drug: Cisplatin, Drug: Nab-Paclitaxel, Radiation: intensity-modulated radiation therapy | Phase 1, Phase 2 | Phase I Maximum Tolerated Dose of Nab-Paclitaxel, Phase II 2-year Progression-free Survival, Phase II 2-year Local Control, Phase II 2-year Overall Survival | 37 | All | NCT00851877 |
| Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI) | Pancreatic Cancer | Drug: Superparamagnetic Iron Oxide Magnetic Resonance Imaging | Phase 4 | To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases., To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases | 35 | All | NCT00920023 |
| Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers | Stage III Intrahepatic Cholangiocarcinoma AJCC v7, Stage IIIA Gallbladder Cancer AJCC v7, Stage IIIB Gallbladder Cancer AJCC v7, and 6 more… | Drug: Cisplatin, Drug: Gemcitabine Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Nab-paclitaxel | Phase 2 | Median Progression Free Survival (PFS), Median Overall Survival (OS), Number of Participants With Treatment Response Rate | 62 | All | NCT02392637 |
| Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2 + MBC | Neoplasms, Breast | Drug: Lapatinib/nab-Paclitaxel | Phase 2 | Overall Tumor Response (OR), Overall Survival (OS), Duration of Response (DOR) | 60 | Female | NCT00709761 |
| A Phase III Study of NK105 in Patients With Breast Cancer | Breast Cancer Nos Metastatic Recurrent | Drug: NK105, Drug: Paclitaxel | Phase 3 | Progression Free Survival, Overall Survival, Overall Response Rate, | 436 | Female | NCT01644890 |
| S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery | Pancreatic Adenocarcinoma, Resectable Pancreatic Carcinoma | Drug: Fluorouracil, Drug: Gemcitabine Hydrochloride, Drug: Irinotecan Hydrochloride, and 3 more… | Phase 2 | Overall Survival (OS), Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy | 147 | All | NCT02562716 |
| Induction Chemotherapy With ACF Followed by Chemoradiation Therapy for Adv. Head & Neck Cancer | Head and Neck Neoplasms | Drug: paclitaxel albumin-stabilized nanoparticle formulation, Drug: Cisplatin, Drug: Fluorouracil, and 3 more… | Phase 2 | Percentage of Participants With Complete Response (CR) by Clinical Exam at Primary Tumor Site, Percentage of Participants With Partial Response (PR) at Primary Tumor Site, Number of Participants Per Anatomic Tumor Response by CT Scan | 30 | All | NCT01566435 |
| Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer | Male Breast Cancer, Recurrent Breast Cancer, Skin Metastases, and 1 more… | Drug: imiquimod, Drug: Abraxane, Other: laboratory biomarker analysis, and 2 more… | Phase 2 | Anti-tumor Effects of Imiquimod as Assessed by Modified World Health Organization (WHO) Criteria, Safety and Systemic Toxicity as Assessed by a Review of Medical History, Physical Exam, Systems, Performance Status, and Clinical Labs (CBC and CMP), Pathologic Response by Immunohistochemical (IHC)as Assessed by Skin Punch Biopsy of the Target Lesion | 15 | All | NCT00821964 |
| Phase 1 Trial of PAN-301–1 (SNS-301) in Cancer Patients | Prostate Cancer | Biological: PAN-301–1 | Phase 1 | Safety Assessed by Development of Adverse Events and Dose-limiting Toxicity to Determine Maximum Tolerated Dose, Safety Assessed by Administration Site Reactions, Abnormal Laboratory Values and/or Clinically Significant Changes in Physical Examinations | 18 | All | NCT00262916 |