Fallopian Tube Cancer Clinical Trial
Official title:
Phase I/II and Pharmacokinetic Study of Docetaxel Plus VEGF Trap (AVE0005, NSC# 724770) in Patients With Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
This phase I/II trial is studying the side effects and best dose of VEGF Trap when given together with docetaxel and to see how well they work in treating patients with persistent or recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving VEGF Trap together with docetaxel may kill more tumor cells
PRIMARY OBJECTIVES:
I. Determine the safety and tolerability of VEGF Trap and docetaxel in patients with
persistent or recurrent ovarian epithelial, primary peritoneal, or fallopian tube cancer.
(Phase I [closed to accrual as of 3/14/2008]) II. Determine the maximum tolerated dose of
VEGF Trap in these patients. (Phase I [closed to accrual as of 3/14/2008]) III. Determine the
pharmacokinetics of VEGF Trap when administered alone and in combination with docetaxel in
these patients. (Phase I [closed to accrual as of 3/14/2008]) IV. Determine the effects of
VEGF Trap on tumor perfusion and metabolism in these patients. (Phase I [closed to accrual as
of 3/14/2008]) V. Determine the effect of VEGF Trap and docetaxel on circulating endothelial
precursors and circulating endothelial cells in these patients. (Phase I [closed to accrual
as of 3/14/2008]) VI. Determine the frequency of clinical response (partial response and
complete response) in patients treated with this regimen. (Phase II [open to accrual as of
5/9/2008]) VII. Determine the progression-free survival (PFS) and overall survival (OS) of
patients treated with this regimen. (Phase II [open to accrual as of 5/9/2008])
SECONDARY OBJECTIVES:
I. Determine the duration of PFS and OS of patients treated with this regimen. (Phase II) II.
Determine the frequency and severity of adverse effects of this regimen in these patients.
(Phase II) III. Determine the proportion of patients with PFS at 6 months. (Phase II)
OUTLINE: This is a multicenter, phase I, dose-escalation study of VEGF Trap followed by a
phase II study.
PHASE I (closed to accrual as of 3/14/2008): Patients receive VEGF Trap IV over 1 hour on day
1 of course 1. Patients then receive VEGF Trap IV over 1 hour and docetaxel IV over 1 hour on
day 1 in all subsequent courses. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of VEGF Trap until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
or 6 patients experience dose-limiting toxicity.
PHASE II (opened to accrual as of 5/9/2008): Patients receive VEGF Trap at the MTD determined
in phase I and docetaxel as in phase I. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.
Patients enrolled in phase I (closed to accrual as of 3/14/2008) undergo blood sample
collection periodically for pharmacokinetic studies and surrogate marker studies. These
patients also undergo dynamic contrast-enhanced MRI, fludeoxyglucose F 18 positron emission
tomography, and CT scan at baseline and on day 1 of courses 1 and 2 to evaluate blood flow
parameters and metabolic activity of tumors. Patients enrolled in phase I (closed to accrual
as of 3/14/2008) and phase II will also undergo blood collection for Anti-VEGF trap antibody.
After the completion of study treatment, patients are followed at 1 and 2 months and then
periodically thereafter.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03393884 -
Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)
|
Phase 1/Phase 2 | |
Completed |
NCT04546373 -
Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
|
||
Active, not recruiting |
NCT05456685 -
IMGN853 With Carboplatin in Second-line Treatment of FRα Expressing, Platinum-sensitive Epithelial Ovarian Cancer
|
Phase 2 | |
Completed |
NCT01442051 -
Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
|
N/A | |
Completed |
NCT02928549 -
Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study
|
||
Active, not recruiting |
NCT03648489 -
Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)
|
Phase 2 | |
Not yet recruiting |
NCT04983550 -
Efficacy and Safety of SG001 Combined With PLD in Patients With Platinum-resistant Relapsed EOC
|
Phase 2 | |
Completed |
NCT02480374 -
Study of Safety & Biological Activity of IP IMNN-001 (Also Known as GEN-1) With Neoadjuvant Chemo in Ovarian Cancer
|
Phase 1 | |
Completed |
NCT01899599 -
PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer
|
Phase 2 | |
Completed |
NCT01610206 -
A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
|
Phase 2 | |
Completed |
NCT03480750 -
Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01219777 -
Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian
|
Phase 1 | |
Completed |
NCT01031381 -
Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer
|
Phase 2 | |
Completed |
NCT00959582 -
Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143)
|
Phase 1 | |
Suspended |
NCT00753480 -
A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
|
Phase 1 | |
Completed |
NCT00801320 -
Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer
|
N/A | |
Completed |
NCT00768144 -
Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
|
Phase 2 | |
Completed |
NCT00702299 -
Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer
|
Phase 1 | |
Recruiting |
NCT02349958 -
Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy
|
Phase 2 | |
Completed |
NCT00390234 -
Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma
|
Phase 2 |