Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-11 @ 4:01 PM
Study NCT ID:
NCT01652794
Status:
COMPLETED
Last Update Posted:
2015-08-04
First Post:
2012-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Phase 1 Study of Carboplatin and Gemcitabine Chemotherapy and Stereotactic Body Radiosurgery for the Palliative Treatment of Persistent or Recurrent Gynecologic Cancer
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this phase I study is to determine the highest dose of carboplatin and gemcitabine (gemcitabine hydrochloride) that can be given safely to subjects with gynecologic cancer, in combination with stereotactic body radiation therapy (SBRT). This dose is called the maximum tolerated dose (MTD). To determine the MTD, patients will receive different amounts of carboplatin and gemcitabine.
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine maximum tolerated carboplatin/gemcitabine dose administered with SBRT as measured by \< 30-day acute toxicity defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
SECONDARY OBJECTIVES:
I. Off-study SBRT target local control assessment: 6-week post-trial fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) or other imaging response by European Organisation for Research and Treatment of Cancer (EORTC) PET criteria as listed and National Cancer Institute (NCI) guidelines.
II. Off-treatment late toxicity assessment: record 3-month and 6-month radiation-related toxicity defined by CTCAE v4.0.
III. Off-study global clinical benefit assessment: 6-month post-therapy clinical benefit (defined as percentage of patients who had complete, partial, or stable disease for at least 6 months).
TERTIARY OBJECTIVES:
I. Associate pretherapy tumor biopsy ribonucleotide reductase (R1, R2, p53R2), Tip60 and Poly(ADP-ribose) polymerase 1/2 expression with 6-week therapy response.
OUTLINE: This is a dose-escalation study of carboplatin and gemcitabine hydrochloride.
Patients also receive carboplatin intravenously (IV) over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1 and undergo SBRT on days 2-4.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then yearly for 2 years.
I. Determine maximum tolerated carboplatin/gemcitabine dose administered with SBRT as measured by \< 30-day acute toxicity defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
SECONDARY OBJECTIVES:
I. Off-study SBRT target local control assessment: 6-week post-trial fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) or other imaging response by European Organisation for Research and Treatment of Cancer (EORTC) PET criteria as listed and National Cancer Institute (NCI) guidelines.
II. Off-treatment late toxicity assessment: record 3-month and 6-month radiation-related toxicity defined by CTCAE v4.0.
III. Off-study global clinical benefit assessment: 6-month post-therapy clinical benefit (defined as percentage of patients who had complete, partial, or stable disease for at least 6 months).
TERTIARY OBJECTIVES:
I. Associate pretherapy tumor biopsy ribonucleotide reductase (R1, R2, p53R2), Tip60 and Poly(ADP-ribose) polymerase 1/2 expression with 6-week therapy response.
OUTLINE: This is a dose-escalation study of carboplatin and gemcitabine hydrochloride.
Patients also receive carboplatin intravenously (IV) over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1 and undergo SBRT on days 2-4.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then yearly for 2 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-00608 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |