Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063934
Status:
TERMINATED
Last Update Posted:
2019-03-05
First Post:
2003-07-08
Brief Title:
Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 12 Study of Bcl-2 Antisense Oligonucleotide G3139 in Combination With Doxorubicin and Docetaxel in Metastatic and Locally Advanced Breast Cancer
Status:
TERMINATED
Status Verified Date:
2019-02
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:
This phase III trial is studying the side effects and best dose of oblimersen when given together with doxorubicin and docetaxel and to see how well they work in treating women with metastatic or locally advanced breast cancer Drugs used in chemotherapy such as doxorubicin and docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die Oblimersen may increase the effectiveness of doxorubicin and docetaxel by making the tumor cells more sensitive to the drugs
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the pharmacokinetics of G3139 doxorubicin and docetaxel in breast cancer patients receiving G3139AT therapy Phase I II To determine the safety of bcl-2 antisense oligonucleotide G3139 GenasenseTM together with docetaxel plus doxorubicin AT in patients with metastatic and locally advanced breast cancer LABC Phase I III To determine the therapeutic efficacy of neoadjuvant G3139 in combination with AT chemotherapy in patients with LABC Phase II IV To further evaluate the safety of bcl-2 antisense oligonucleotide G3139 GenasenseTM together with docetaxel plus doxorubicin AT in patients with locally advanced breast cancer LABC Phase II
SECONDARY OBJECTIVES
I To determine the clinical and imaging response to neoadjuvant G3139AT in the breast and the axillary lymph nodes Phase II II To determine the disease-free survival of breast cancer patients treated with neoadjuvant G3139AT Phase II III To further define the pharmacokinetics of G3139AT Phase II IV To evaluate the role of Bcl-2 expression as a predictor of response to neoadjuvant G3139AT therapy Phase II V To obtain serial breast cancer samples from patients treated with G3139 Phase II
OUTLINE This is an open-label dose-escalation study of oblimersen
PHASE I COMPLETED AS OF 81604 Patients receive oblimersen IV continuously on days 1-6 interrupted only to administer doxorubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 6 Patients also receive filgrastim G-CSF subcutaneously SC on days 7-13 or pegfilgrastim SC on day 7 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PHASE II Patients receive doxorubicin docetaxel G-CSF or pegfilgrastim and oblimersen at the MTD as in phase I
Patients with resectable tumors after 6 courses undergo surgical resection
Patients are followed every 3-6 months for 5 years
I To evaluate the pharmacokinetics of G3139 doxorubicin and docetaxel in breast cancer patients receiving G3139AT therapy Phase I II To determine the safety of bcl-2 antisense oligonucleotide G3139 GenasenseTM together with docetaxel plus doxorubicin AT in patients with metastatic and locally advanced breast cancer LABC Phase I III To determine the therapeutic efficacy of neoadjuvant G3139 in combination with AT chemotherapy in patients with LABC Phase II IV To further evaluate the safety of bcl-2 antisense oligonucleotide G3139 GenasenseTM together with docetaxel plus doxorubicin AT in patients with locally advanced breast cancer LABC Phase II
SECONDARY OBJECTIVES
I To determine the clinical and imaging response to neoadjuvant G3139AT in the breast and the axillary lymph nodes Phase II II To determine the disease-free survival of breast cancer patients treated with neoadjuvant G3139AT Phase II III To further define the pharmacokinetics of G3139AT Phase II IV To evaluate the role of Bcl-2 expression as a predictor of response to neoadjuvant G3139AT therapy Phase II V To obtain serial breast cancer samples from patients treated with G3139 Phase II
OUTLINE This is an open-label dose-escalation study of oblimersen
PHASE I COMPLETED AS OF 81604 Patients receive oblimersen IV continuously on days 1-6 interrupted only to administer doxorubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 6 Patients also receive filgrastim G-CSF subcutaneously SC on days 7-13 or pegfilgrastim SC on day 7 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PHASE II Patients receive doxorubicin docetaxel G-CSF or pegfilgrastim and oblimersen at the MTD as in phase I
Patients with resectable tumors after 6 courses undergo surgical resection
Patients are followed every 3-6 months for 5 years
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 |
|---|---|---|---|
| N01CM17003 | NIH | CTEP | httpsreporternihgovquickSearchN01CM17003 |
| NCI-2012-02885 | REGISTRY | None | None |
| 6023 | None | None | None |
| DM02-700 | OTHER | None | None |
| 6023 | OTHER | None | None |
| P30CA016672 | NIH | None | None |