Clinical trial NCT02421588: Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
Official title: Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) Versus Pegylated Liposomal Doxorubicin or Topotecan in Patients With Platinum-resistant Ovarian Cancer (CORAIL Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Lead sponsor: PharmaMar
Sponsor class: INDUSTRY
First posted: 2015-04-20
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).


Eligibility criteria: Inclusion Criteria:

* Age \>/= 18 years
* Confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer.
* Platinum-resistant disease (PFI: 1-6 months after last platinum-containing chemotherapy).
* Evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria
* No more than three prior systemic chemotherapy regimens
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) (ECOG PS) ≤ 2
* Adequate hematological, renal, metabolic and hepatic function

Exclusion Criteria:

* Concomitant diseases/conditions: cardiac disease, immunodeficiency, chronic active hepatitis or cirrhosis, uncontrolled infection, bowel obstruction, any other major illness
* Prior treatment with PM01183, trabectedin, or with both PLD and topotecan.
* Requirement of permanent or frequent (i.e., once per week) external drainages within two weeks prior to randomization

Primary outcomes:
measure: Progression-free Survival by Independent Review Committee
timeFrame: Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years
Secondary outcomes:
measure: Progression-free Survival by Investigator's Assessment
timeFrame: Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years
measure: Overall Survival (OS)
timeFrame: From the date of randomization to the date of death or last contact, up to 12 months after last patient inclusion, for a maximum of up to 3 years
measure: Overall Response Rate (ORR) by Independent Review Committee
timeFrame: At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years
measure: Overall Response Rate by Investigator's Assessment
timeFrame: At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years
measure: Duration of Response by Independent Review Committee
timeFrame: The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years
measure: Duration of Response by Investigator's Assessment
timeFrame: The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years
measure: Best Response According to Tumor Marker Evaluation (CA-125)
timeFrame: At baseline and every eight weeks from randomization until evidence of PD, up to 3 years
Other outcomes:
Locations:
city: Peoria
country: United States
facility: 1112
state: Arizona
city: Greenbrae
country: United States
facility: 1102
state: California
city: La Jolla
country: United States
facility: 1103
state: California
city: Los Angeles
country: United States
facility: 1116
state: California
city: Los Angeles
country: United States
facility: 1120
state: California
city: Palo Alto
country: United States
facility: 1113
state: California
city: San Francisco
country: United States
facility: 1111
state: California
city: Santa Maria
country: United States
facility: 1122
state: California
city: West Hills
country: United States
facility: 1123
state: California
city: Augusta
country: United States
facility: 1109
state: Georgia
city: Indianapolis
country: United States
facility: 1104
state: Indiana
city: Covington
country: United States
facility: 1110
state: Louisiana
city: Scarborough
country: United States
facility: 1124
state: Maine
city: Brick
country: United States
facility: 1121
state: New Jersey
city: Albany
country: United States
facility: 1127
state: New York
city: New York
country: United States
facility: 1105
state: New York
city: Asheville
country: United States
facility: 1117
state: North Carolina
city: Charlotte
country: United States
facility: 1101
state: North Carolina
city: Charlotte
country: United States
facility: 1125
state: North Carolina
city: Durham
country: United States
facility: 1108
state: North Carolina
city: Columbus
country: United States
facility: 1107
state: Ohio
city: Dayton
country: United States
facility: 1118
state: Ohio
city: Pittsburgh
country: United States
facility: 1119
state: Pennsylvania
city: Greenville
country: United States
facility: 1115
state: South Carolina
city: Nashville
country: United States
facility: 1129
state: Tennessee
city: Fort Worth
country: United States
facility: 1131
state: Texas
city: Houston
country: United States
facility: 1128
state: Texas
city: Charlottesville
country: United States
facility: 1106
state: Virginia
Study officials:
References:
citation: Gaillard S, Oaknin A, Ray-Coquard I, Vergote I, Scambia G, Colombo N, Fernandez C, Alfaro V, Kahatt C, Nieto A, Zeaiter A, Aracil M, Vidal L, Pardo-Burdalo B, Papai Z, Kristeleit R, O'Malley DM, Benjamin I, Pautier P, Lorusso D. Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL). Gynecol Oncol. 2021 Nov;163(2):237-245. doi: 10.1016/j.ygyno.2021.08.032. Epub 2021 Sep 11.