Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006262
Status:
TERMINATED
Last Update Posted:
2012-06-11
First Post:
2000-09-11
Brief Title:
Rebeccamycin Analogue in Treating Patients With Refractory Stage III or Stage IV Ovarian Epithelial Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase 2 Study of BMY-27557-14 a Rebeccamycin Analog in Patients With Ovarian Cancer
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to accrue patients to the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of rebeccamycin analogue in treating patients who have refractory stage III or stage IV ovarian epithelial cancer
PURPOSE Phase II trial to study the effectiveness of rebeccamycin analogue in treating patients who have refractory stage III or stage IV ovarian epithelial cancer
Detailed Description:
OBJECTIVES I Determine the response rate to rebeccamycin analogue in patients with refractory stage III or IV ovarian epithelial cancer who have failed platinum in combination with paclitaxel chemotherapy II Determine the toxicities of this treatment regimen in these patients
OUTLINE Patients receive rebeccamycin analogue IV over 60 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients with complete response after receiving 3 courses receive 3-6 additional courses Patients with partial response or stable disease after receiving 3 courses receive 3-12 additional courses Patients with complete response are followed every 2 months for 2 years and then every 3 months thereafter All other patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-39 patients will be accrued for this study
OUTLINE Patients receive rebeccamycin analogue IV over 60 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients with complete response after receiving 3 courses receive 3-6 additional courses Patients with partial response or stable disease after receiving 3 courses receive 3-12 additional courses Patients with complete response are followed every 2 months for 2 years and then every 3 months thereafter All other patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-39 patients will be accrued for this study
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-1132 | None | None | None |
| NU-NCI-00G1 | None | None | None |