Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004189
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2000-01-21
Brief Title:
Rebeccamycin Analog and Cisplatin With or Without Filgrastim in Treating Patients With Advanced Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I and Pharmacokinetic Study of Sequences of NSC 655649 Rebeccamycin Analogue and Cisplatin Without and With Granulocyte Colony-Stimulating Factor Support Every 21 Days
Status:
COMPLETED
Status Verified Date:
2003-09
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:
Phase I trial to study the effectiveness of rebeccamycin analog and cisplatin with or without filgrastim in treating patients who have advanced cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated doses of a rebeccamycin analogue and cisplatin with or without filgrastim G-CSF in patients with advanced malignancies
II Determine the qualitative and quantitative toxicities of these regimens in these patients
III Determine if the pharmacokinetics of a rebeccamycin analogue are affected by cisplatin and if there are sequence dependent pharmacokinetic effects
IV Assess any antitumor effects of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study of a rebeccamycin analogue and cisplatin
Part I previously untreated or minimally pretreated patients The first patient of each cohort receives cisplatin IV over 1 hour followed 2 hours later by a rebeccamycin analogue IV over 1 hour on day 1 The second patient in the same cohort receives the same drugs in the reverse order The drug sequence for each additional patient within the same cohort is alternated with reference to the preceding patient During each subsequent course the study drugs are administered to each patient in the reverse order as compared to the prior course Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Dose escalation is initially performed without filgrastim G-CSF Cohorts of 4-6 patients receive escalating doses of a rebeccamycin analogue and cisplatin until the maximum tolerated dose MTD of each drug is determined The MTD is defined as the highest dose at which less than 2 of 6 patients experience dose limiting toxicity DLT If 2 of the first 6 patients experience DLT then dose escalation proceeds in combination with G-CSF treatment Patients receive G-CSF subcutaneously daily beginning on day 2 and continuing until blood counts have recovered for 2 days or until approximately day 15 Cohorts of 4-6 patients receive escalating doses of a rebeccamycin analogue and cisplatin as above The MTD is defined as above
Part II heavily pretreated patients Heavily pretreated patients receive a rebeccamycin analogue and cisplatin starting at 2 dose levels preceding the MTD from part I
Patients are followed for at least 30 days
I Determine the maximum tolerated doses of a rebeccamycin analogue and cisplatin with or without filgrastim G-CSF in patients with advanced malignancies
II Determine the qualitative and quantitative toxicities of these regimens in these patients
III Determine if the pharmacokinetics of a rebeccamycin analogue are affected by cisplatin and if there are sequence dependent pharmacokinetic effects
IV Assess any antitumor effects of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study of a rebeccamycin analogue and cisplatin
Part I previously untreated or minimally pretreated patients The first patient of each cohort receives cisplatin IV over 1 hour followed 2 hours later by a rebeccamycin analogue IV over 1 hour on day 1 The second patient in the same cohort receives the same drugs in the reverse order The drug sequence for each additional patient within the same cohort is alternated with reference to the preceding patient During each subsequent course the study drugs are administered to each patient in the reverse order as compared to the prior course Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Dose escalation is initially performed without filgrastim G-CSF Cohorts of 4-6 patients receive escalating doses of a rebeccamycin analogue and cisplatin until the maximum tolerated dose MTD of each drug is determined The MTD is defined as the highest dose at which less than 2 of 6 patients experience dose limiting toxicity DLT If 2 of the first 6 patients experience DLT then dose escalation proceeds in combination with G-CSF treatment Patients receive G-CSF subcutaneously daily beginning on day 2 and continuing until blood counts have recovered for 2 days or until approximately day 15 Cohorts of 4-6 patients receive escalating doses of a rebeccamycin analogue and cisplatin as above The MTD is defined as above
Part II heavily pretreated patients Heavily pretreated patients receive a rebeccamycin analogue and cisplatin starting at 2 dose levels preceding the MTD from part I
Patients are followed for at least 30 days
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T98-0069 | None | None | None |
| UTHSC-IDD-98-34 | None | None | None |
| SACI-IDD-98-34 | None | None | None |