Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase II Open Label Pilot Trial of Empiric Daptomycin Treatment for Oncology Patients With Neutropenic Fever
RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in
patients with cancer.
PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia
and fever in patients with cancer.
OBJECTIVES:
Primary
- Assess the response rate to therapy within 72 hours of starting daptomycin in cancer
patients with neutropenic fever.
Secondary
- Assess the percentage of bacterial cures in patients with documented gram-positive
bacterial infections.
- Assess time to afebrile state.
- Assess the pharmacokinetic data of daptomycin in neutropenic patients.
- Document the incidence of breakthrough infections that require a change of therapy or
additional agents to clear.
- Assess the tolerability of daptomycin in neutropenic patients.
- Assess and document adverse events and toxicity due to daptomycin.
OUTLINE: This is an open-label, pilot study.
Patients first receive standard treatment for gram-negative bacteria for 72 hours. If the
patient is still febrile at 72 hours, daptomycin is administered.
Patients receive daptomycin IV over 30 minutes once daily. Patients who are afebrile, not
neutropenic (absolute neutrophil count [ANC] > 500/mm³), and have no signs of infection
after 72 hours of therapy may discontinue daptomycin. Patients who are afebrile and
neutropenic (ANC < 500/mm³) after 72 hours of therapy continue to receive daptomycin until
absolute neutrophil count (ANC) > 500/mm³ for 2 consecutive days. Patients who are febrile
with or without continued neutropenia (ANC < 500/mm³) after 72 hours of therapy continue to
receive daptomycin for up to 10-14 days in the absence of unacceptable toxicity.
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
|
||
| Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
| Completed |
NCT00924651 -
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
|
Phase 3 | |
| Completed |
NCT00949949 -
Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
|
Phase 1 | |
| 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 |
NCT00573690 -
Sorafenib Combined With Cisplatin and Etoposide or Carboplatin and Pemetrexed in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| 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 | |
| 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 |
NCT00121277 -
Vorinostat and Capecitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
|
Phase 1 | |
| Completed |
NCT00255658 -
Sorafenib and Temsirolimus in Treating Patients With Unresectable or Metastatic Solid Tumors
|
Phase 1 |