Ovarian Cancer Clinical Trial
Official title:
A Multi-National Randomized Phase-III GCIG Intergroup-Study Comparing 1st-line Chemotherapy With Gemcitabine/Paclitaxel/Carboplatin vs Paclitaxel/Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV
RATIONALE: 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. It is
not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective
than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube
cancer.
PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined
with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in
treating patients who have undergone surgery for ovarian epithelial or fallopian tube
cancer.
OBJECTIVES:
- Compare overall survival in patients with stage I-IV ovarian epithelial or fallopian
tube cancer treated with adjuvant carboplatin and paclitaxel with or without
gemcitabine.
- Compare response rates, progression-free survival, and duration of response in patients
treated with these regimens.
- Compare toxic effects of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are
stratified according to FIGO stage (I-IIA vs IIB-IIIC and tumor no greater than 10 mm vs
IIB-IIIC and tumor greater than 10 mm or IV), plan for interval surgical debulking (yes vs
no), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive carboplatin IV over 30-60 minutes and paclitaxel IV over 3
hours on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8.
- Arm II: Patients receive carboplatin and paclitaxel as in arm I. Treatment in both arms
repeats every 21 days for 6 to 10 courses in the absence of disease progression or
unacceptable toxicity.
Some patients undergo interval debulking surgery.
Quality of life is assessed at baseline, after courses 3 and 6, and then at 3, 6, and 12
months after completion of study.
Patients are followed every 3 months for 2 years, every 6 months for up to 5 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 1,716 patients (858 per treatment arm) will be accrued for
this study within 2 years.
;
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Withdrawn |
NCT05201001 -
APX005M in Patients With Recurrent Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
| Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
| Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05156892 -
Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer
|
Phase 1 | |
| Suspended |
NCT02432378 -
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04533763 -
Living WELL: A Web-Based Program for Ovarian Cancer Survivors
|
N/A | |
| Active, not recruiting |
NCT03371693 -
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
|
Phase 3 | |
| Withdrawn |
NCT03032614 -
Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
|
Phase 2 | |
| Completed |
NCT01936363 -
Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT02019524 -
Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
|
Phase 1 | |
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
| Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
| Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
| Terminated |
NCT03146663 -
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
|
Phase 2 |