Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
An Open-Label, Pilot Study of Daptomycin vs. Vancomycin for Treatment of Gram-Positive Bacteremia in Neutropenic Cancer Patients
RATIONALE: Antibiotics, such as daptomycin and vancomycin, may be effective in treating
bacteria in the blood. It is not yet known whether daptomycin is more effective than
vancomycin in treating bacteria in the blood in patients with neutropenia caused by
chemotherapy.
PURPOSE: This randomized clinical trial is studying daptomycin to see how well it works
compared with vancomycin in treating bacteria in the blood in patients with neutropenia
caused by chemotherapy.
OBJECTIVES:
Primary
- Compare the safety of daptomycin vs vancomycin in cancer patients with
chemotherapy-induced neutropenia and gram-positive bacteremia.
- Compare the efficacy of these drugs, in terms of fever resolution, bacteremia
resolution, inflammation indicators reduction, implanted catheter salvage, and reduced
need for antifungal therapy, in these patients.
OUTLINE: This is an open-label, randomized, pilot study. Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive daptomycin IV over 30 minutes once daily.
- Arm II: Patients receive vancomycin IV over 60 minutes twice daily. Treatment in both
arms continues for approximately 7-14 days or until microbiologic failure,
unsatisfactory clinical (symptomatic) response, or fever and neutropenia is resolved
(absolute neutrophil count ≥ 1,000/mm^3 on ≥ 2 consecutive days). Patients may be
removed from the study if the isolate is found to be sensitive to the original
antibiotics or resistant to either of the study drugs.
After completion of study therapy, patients are followed at 6 and 12 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01828775 -
Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment
|
N/A | |
| Terminated |
NCT01642342 -
Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00002950 -
Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01705548 -
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
|
N/A | |
| Completed |
NCT02146222 -
VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Docetaxel in Treating Patients With Solid Tumors
|
Phase 1 | |
| Terminated |
NCT01602627 -
Hsp90 Inhibitor AUY922 in Treating Older Patients With Advanced Solid Malignancies
|
Phase 1 | |
| Completed |
NCT01191216 -
1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT01137825 -
Registry of Older Patients With Cancer
|
||
| Recruiting |
NCT00992303 -
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
|
||
| Completed |
NCT00949949 -
Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
|
Phase 1 | |
| Completed |
NCT00924651 -
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
|
Phase 3 | |
| Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
| Withdrawn |
NCT00937417 -
S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT00710632 -
Screening to Predict Weight Loss in Patients With Cancer
|
N/A | |
| Completed |
NCT00544596 -
R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer
|
Phase 1 | |
| Completed |
NCT00573690 -
Sorafenib Combined With Cisplatin and Etoposide or Carboplatin and Pemetrexed in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT00436735 -
Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00352443 -
S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00128622 -
Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT00126620 -
Sorafenib and Erlotinib in Treating Patients With Metastatic or Unresectable Solid Tumors
|
Phase 1 |