Pulsed Abraxane and Radiotherapy for Improving and Mainta... | NCT03655080

NCT03655080

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Celgene	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nab-Paclitaxel and Radiation Therapy	Experimental	10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks	Radiation: Radiation therapy Drug: nab-Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
Radiation therapy	Radiation	Using the View Ray System	nab-Paclitaxel and Radiation Therapy

Measure	Description	Time Frame
Ambulatory Status	-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.	1 month

Measure	Description	Time Frame
Ambulatory Status	-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.	3 months
Ambulatory Status

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with ≤ 37 points per the scoring system listed in the protocol
Histologically or cytologically confirmed diagnosis of cancer not of CNS or spinal column origin.
MRI or CT evidence of metastatic epidural spinal cord compression.
Patients who have started 30 Gy in 10 fractions are not excluded as long as 4 doses of chemotherapy could potentially be given. This means the latest nab-paclitaxel can start is the morning of the third fraction of radiotherapy. Radiotherapy should ideally be delivered at least 6 hours after the nab-paclitaxel infusion started.
At least 18 years of age.
Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1,500 cells/mm3
- Platelets ≥ 100,000 cells/mm3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to blood draw)
- Hemoglobin > 9.0 g/dL
- Total bilirubin ≤ 1.5 mg/dL
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
- Alkaline phosphatase ≤ 2.5 x IULN (unless bone metastasis is present (< 5 x IULN) in the absence of liver metastasis)
- Creatinine ≤ 1.5 mg/dL
Women of childbearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy or bilateral oophorectomy or (2) has not been naturally postmenopausal for at least 24 consecutive months) must:
- Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting treatment with nab-paclitaxel and while on study; and
- Have a negative serum pregnancy test result at screening and agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the subject practices true abstinence from heterosexual contact.
Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 6 months following nab-paclitaxel discontinuation, even if he has undergone a successful vasectomy.
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test prior to study entry.
Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with nab-paclitaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Previous spinal cord radiotherapy that would overlap with the proposed treatment field.
Spinal instability or bony retropulsion causing the cord compression. That is, mechanical, not tumor, cord compression. In these cases surgery may be indicated.
Patients eligible for surgical decompression like laminectomy.

Name	Affiliation	Role
Hiram A Gay, M.D.	Washington University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

Label	URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine	View source

ID	Title	Description
FG000	Nab-Paclitaxel and Radiation Therapy	10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Nab-Paclitaxel and Radiation Therapy	10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Median

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Ambulatory Status

-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.

One participant was not evaluable for this outcome measure because the ambulatory status was not completed for the participant.

Posted

Count of Participants

Participants

1 month

ID	Title	Description
OG000	Nab-Paclitaxel and Radiation Therapy	10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nab-Paclitaxel and Radiation Therapy	10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D013119	Spinal Cord Injuries

ID	Term
D011878	Radiotherapy
C520255	130-nm albumin-bound paclitaxel
D000068196	Albumin-Bound Paclitaxel

ID	Term
D013812	Therapeutics
D017239	Paclitaxel
D043823	Taxoids
D043822	Cyclodecanes
D003516