Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285415
Status:
TERMINATED
Last Update Posted:
2021-02-05
First Post:
2006-01-31
Brief Title:
A Phase II Evaluation of Docetaxel and Carboplatin Followed by Tumor Volume Directed Pelvic Irradiation
Sponsor:
Carilion Clinic
Organization:
Carilion Clinic
Study Overview
Official Title:
A Phase II Evaluation of Docetaxel and Carboplatin Followed by Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation for Stage IIIIV Endometrial Carcinoma
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator abruptly left Carilion
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 study is to determine the effectiveness of the combination of the two drugs docetaxel Taxotere and carboplatin Paraplatin followed by radiation directed at the tumor in treating your endometrial cancer
Detailed Description:
Endometrial carcinoma is the most common malignancy in the female reproductive tract For the percentage of patients with advanced stage III - IV optimum adjuvant therapy status-post surgical staging andor optimal cytoreductive surgery is not well defined and limited in the rates of response Survival rates range from 18 - 49 with high levels of toxicity with the current treatment regimens
The Gynecologic Oncology Group GOG explored the use of chemotherapy in protocol 107 comparing adriamycin with a combination of adriamycin and cisplatin This trial boasted a 45 response rate for the combination arm compared to a 27 response rate in the adriamycin only arm Although no difference was seen in overall survival the combination arm showed an improvement in progression free survival from 38 to 57 months Subsequently GOG protocol 122 randomized patients to this chemotherapeutic regimen versus whole abdominal radiation therapy This trial is now closed to accrual and results are pending
Ball et al reported on a phase II trial of paclitaxel in advanced or recurrent endometrial cancer done through the GOG3 At 250 mgm2 200mgm2 for patients with previous radiation therapy over 24 hours every 21 days 1028 patients responded There were 4 complete responders and 6 partial responders with an overall response rate of 357 Toxicity was remarkably high with grade 3 and 4 neutropenia and neurotoxicity seen in 62 and 107 respectively
Dimpoulos et al reported the use of paclitaxel 175 mgm2 over 3 hours and cisplatin 75mgm2 every 21 days in advanced or recurrent endometrial carcinoma4 A 67 objective response rate was seen with 29 showing a complete response and 38 partial response Toxicities included a 9 grade 3 and 4 peripheral neuropathy rate These response rates changed the standard of care in the community setting from the more toxic regimen of adriamycin and cisplatin to paclitaxel and carboplatin
Hoskins et al substituted carboplatin for cisplatin in an effort to reduce the peripheral neuropathy seen in the Dimpoulos trial This phase II combination of paclitaxel and carboplatin with radiation therapy in advanced endometrial cancer resulted in a 75 response rate The median failure-free survival time was 23 months with a 62 3-year overall survival rate Toxicities were primarily hematologic and reversible
The ongoing GOG protocol 184 is exploring the combination of tumor directed radiation followed by a randomization to adriamycin and cisplatin versus adriamycin cisplatin and paclitaxel with G-CSF support Increased toxicity will be expected in the three-drug regimen With a significant response rates to a combination of paclitaxel and carboplatin along with radiation therapy in the phase II setting it is hard to justify the added toxicity of this three-drug regimen
The SCOTROC phase III trial comparing docetaxel 75 mgm2 over 1 hour plus carboplatin AUC 6 vs paclitaxel 175 mgm2 over 3 hours plus carboplatin AUC 6 yielded equivalent overall response rates in 1077 patients with ovarian cancer The docetaxel arm resulted in significantly less overall grade 2 and 3 sensory and motor neurotoxicity Only 4 patients withdrew from the trial due to neurotoxicity on the docetaxel arm vs 32 patients on the paclitaxel arm However the docetaxel arm resulted in a higher incidence of neutropenia and associated complications without compromising treatment delivery of overall safety
Based on the information to date it seems prudent to explore a phase II trial of docetaxel plus carboplatin every 3 weeks for 6 cycles followed by radiation therapy in the management of patients with advanced endometrial cancer The proposed protocol design requires that chemotherapy be administered prior to radiation therapy in order to control distant metastatic disease before attempting to control for local-regional recurrences with radiation
The Gynecologic Oncology Group GOG explored the use of chemotherapy in protocol 107 comparing adriamycin with a combination of adriamycin and cisplatin This trial boasted a 45 response rate for the combination arm compared to a 27 response rate in the adriamycin only arm Although no difference was seen in overall survival the combination arm showed an improvement in progression free survival from 38 to 57 months Subsequently GOG protocol 122 randomized patients to this chemotherapeutic regimen versus whole abdominal radiation therapy This trial is now closed to accrual and results are pending
Ball et al reported on a phase II trial of paclitaxel in advanced or recurrent endometrial cancer done through the GOG3 At 250 mgm2 200mgm2 for patients with previous radiation therapy over 24 hours every 21 days 1028 patients responded There were 4 complete responders and 6 partial responders with an overall response rate of 357 Toxicity was remarkably high with grade 3 and 4 neutropenia and neurotoxicity seen in 62 and 107 respectively
Dimpoulos et al reported the use of paclitaxel 175 mgm2 over 3 hours and cisplatin 75mgm2 every 21 days in advanced or recurrent endometrial carcinoma4 A 67 objective response rate was seen with 29 showing a complete response and 38 partial response Toxicities included a 9 grade 3 and 4 peripheral neuropathy rate These response rates changed the standard of care in the community setting from the more toxic regimen of adriamycin and cisplatin to paclitaxel and carboplatin
Hoskins et al substituted carboplatin for cisplatin in an effort to reduce the peripheral neuropathy seen in the Dimpoulos trial This phase II combination of paclitaxel and carboplatin with radiation therapy in advanced endometrial cancer resulted in a 75 response rate The median failure-free survival time was 23 months with a 62 3-year overall survival rate Toxicities were primarily hematologic and reversible
The ongoing GOG protocol 184 is exploring the combination of tumor directed radiation followed by a randomization to adriamycin and cisplatin versus adriamycin cisplatin and paclitaxel with G-CSF support Increased toxicity will be expected in the three-drug regimen With a significant response rates to a combination of paclitaxel and carboplatin along with radiation therapy in the phase II setting it is hard to justify the added toxicity of this three-drug regimen
The SCOTROC phase III trial comparing docetaxel 75 mgm2 over 1 hour plus carboplatin AUC 6 vs paclitaxel 175 mgm2 over 3 hours plus carboplatin AUC 6 yielded equivalent overall response rates in 1077 patients with ovarian cancer The docetaxel arm resulted in significantly less overall grade 2 and 3 sensory and motor neurotoxicity Only 4 patients withdrew from the trial due to neurotoxicity on the docetaxel arm vs 32 patients on the paclitaxel arm However the docetaxel arm resulted in a higher incidence of neutropenia and associated complications without compromising treatment delivery of overall safety
Based on the information to date it seems prudent to explore a phase II trial of docetaxel plus carboplatin every 3 weeks for 6 cycles followed by radiation therapy in the management of patients with advanced endometrial cancer The proposed protocol design requires that chemotherapy be administered prior to radiation therapy in order to control distant metastatic disease before attempting to control for local-regional recurrences with radiation
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 |
|---|---|---|---|
| WIRB PRO NUM 20050247 | OTHER | Western Institutional Review Board | None |