Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005021
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2000-04-06
Brief Title:
Combination Chemotherapy With or Without Biological Therapy in Treating Patients With Refractory Solid Tumor or Lymphoma
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase I Evaluation of Topotecan in Combination With Paclitaxel and Carboplatin
Status:
COMPLETED
Status Verified Date:
2013-07
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug giving the drugs in different ways and combining biological therapy with chemotherapy may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of topotecan paclitaxel and carboplatin with or without filgrastim in treating patients who have advanced solid tumor or lymphoma that has not responded to standard therapy
PURPOSE Phase I trial to study the effectiveness of topotecan paclitaxel and carboplatin with or without filgrastim in treating patients who have advanced solid tumor or lymphoma that has not responded to standard therapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated doses of combined topotecan paclitaxel and carboplatin TOPOTAXCBDCA with or without filgrastim G-CSF in patients with advanced solid tumors or lymphomas II Determine the toxic effects of this regimen in these patients III Determine the pharmacokinetics of TOPOTAXCBDCA and whether TAXCBDCA will affect the pharmacokinetics of TOPO on day 1 as compared to TOPO administered alone on day 3 IV Describe any clinical responses observed in these patients
OUTLINE This is a dose escalation study of the combination topotecanpaclitaxelcarboplatin Patients are stratified according to prior chemotherapy and radiotherapy yes vs no Part I Patients receive topotecan IV on days 1-3 and paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1 Part II Patients receive topotecan paclitaxel and carboplatin as in part I plus filgrastim G-CSF on days 6-19 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of topotecanpaclitaxelcarboplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 20-30 patients will be accrued for this study within 4 years
OUTLINE This is a dose escalation study of the combination topotecanpaclitaxelcarboplatin Patients are stratified according to prior chemotherapy and radiotherapy yes vs no Part I Patients receive topotecan IV on days 1-3 and paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1 Part II Patients receive topotecan paclitaxel and carboplatin as in part I plus filgrastim G-CSF on days 6-19 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of topotecanpaclitaxelcarboplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 20-30 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| NCI-T95-0075H | OTHER_GRANT | National Cancer Institute | None |
| CDR0000064913 | REGISTRY | None | None |