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
Verified date | May 2017 |
Source | OHSU Knight Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | October 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of cancer - Diagnosis of neutropenic fever - Temperature > 38.3°C once OR = 38°C twice within 12 hours - Absolute neutrophil count < 500/mm^³ and = 1 of the following: - Mucositis - Concurrent skin or soft tissue infection - Indwelling catheter and/or suspected catheter infection - Recent quinolone prophylaxis - Positive blood cultures for gram-positive cocci before final identification or other documented gram-positive pathogen - Colonization with ß-lactam resistant gram-positive organisms (commonly the nares or the skin) - Hypotension, tachycardia, narrowed pulse pressures, tachypnea, or other signs of cardiovascular compromise - Expected duration of neutropenia = 3 days - No known infection with daptomycin-resistant organism or gram-negative organism and not yet meeting criteria for the addition of gram-positive antimicrobial therapy - No suspected meningitis or osteomyelitis - No documented or suspected gram-positive pneumonia - No suspected or proven endocarditis PATIENT CHARACTERISTICS: - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Life expectancy = 2 weeks - Creatinine clearance = 50 mL/min - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective double-method contraception - No known sensitivity to daptomycin or product excipients - No history of or concurrent rhabdomyolysis - No HIV positivity - No psychiatric disorders that would preclude study compliance - No signs or symptoms of myopathy with creatine phosphokinase (CPK) elevation > 1,000 U/L (5 times upper limit of normal [ULN]) - No CPK elevations > 10 times ULN in patients with no signs or symptoms of myopathy PRIOR CONCURRENT THERAPY: - See Disease Characteristics - At least 7 days since prior daptomycin or other antibiotic agents covering gram-positive organisms - No concurrent hemodialysis or continuous ambulatory peritoneal dialysis - No concurrent succinylcholine, ethanol, fludrocortisone, olanzapine, or pioglitazone - No concurrent hydroxymethyl glutaryl (HMG) coenzyme A (HMG CoA) reductase inhibitors (e.g., lovastatin, simvastatin, atorvastatin) - Concurrent therapy for gram-negative bacterial infection allowed |
Country | Name | City | State |
---|---|---|---|
United States | OHSU Knight Cancer Institute | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
OHSU Knight Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin. | If after 72 hours of daptomycin treatment, the patient is afebrile and has absolute neutrophil count (ANC) >500 cells/mm^3 for 48 hours with no site of infection, negative cultures, and no clinical indications for therapy, the antibiotic regimen will be discontinued. Complete Response: Resolution of fever and clinical signs/symptoms of infection. Partial Response: Resolution of fever without resolution of clinical signs of infection. |
Within 72 hours of starting daptomycin |
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 |
NCT00121277 -
Vorinostat and Capecitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
|
Phase 1 |