Clinical trial NCT00090610: Second-Line Treatment for Patients With Platinum-Sensitive Ovarian Cancer
Official title: Multicenter, Randomized, Phase II Comparative Study to Compare Efficacy & Safety of Taxotere®/Carboplatin Combination Therapy vs Sequential Therapy w/ Taxotere® Then Carboplatin as Second-line Treatment of Patients w/ Relapsed, Platinum-sensitive Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: Relapsed ovarian cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
First posted: 2004-08-31
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the progression-free survival of two treatment regimens for relapsed ovarian cancer.

Detailed description: Primary Objective

The primary objective of the study is to compare the progression-free survival of two treatment regimens:

Taxotere® 30 mg/m2 IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days for 6 cycles or until disease progression. (A patient who has completed 6 cycles of treatment and who has achieved a partial response or stable disease may either continue or stop treatment at the investigator's discretion.)

Versus

Taxotere® 30 mg/m2 IV on Days 1 and 8, repeated every 21 days up to 6 cycles or until disease progression. Followed by carboplatin (AUC 6) IV every 21 days if the patient does not achieve a complete response or has disease progression on Taxotere®. A patient who has achieved a complete response on Taxotere® will be followed until the subsequent recurrence at which time she will then receive single-agent carboplatin. Carboplatin treatment will be discontinued if the patient has completed 6 cycles of treatment and has achieved a complete response or has disease progression. (A patient who has completed 6 cycles of carboplatin treatment and who has achieved a partial response or stable disease may either continue or stop treatment at the investigator's discretion.)

Secondary Objectives

The secondary objectives of the study are to compare the objective response rates (defined as a complete response plus partial response), duration of tumor response, median survival, QOL and safety in patients treated with the two regimens described above.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or tubal carcinoma.
* The patient's tumor is platinum-sensitive, which means that the patient had a complete response to front-line treatment with a platinum compound and had a treatment-free interval without clinical evidence of progressive disease for greater than 6 months.
* The patient has received one and only one prior chemotherapy regimen for the treatment of this malignancy. Prior treatment with paclitaxel and/or a platinum compound is allowed. Patients who have received consolidation treatment are allowed. Prior treatment with Taxotere® is not allowed.

  o Consolidation therapy is allowed including a different cytotoxic agent than the agent used in the front-line regimen, intraperitoneal therapy, biologic therapy, and immunotherapy.
* Patients may have received one prior regimen with a biologic therapy, either combined with cytotoxic therapy in the front-line setting, or as a single-agent for this recurrence. The biologic therapy must be discontinued at least three weeks prior to registration.
* Measurable or evaluable disease either by radiologic imaging, or physical exam, or by measurement of CA125 \< 70 on two occasions at least one week apart.
* At least 3 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal.
* At least 3 weeks since major surgery, with full recovery. Patients who have undergone a secondary tumor debulking or cytoreductive surgery for this malignancy are excluded.
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
* Age \> 18 years.
* Absolute neutrophil count \> 1,500/mm3; platelet count \> 100,000/mm3; Hemoglobin \> 8.0 g/dl
* Serum bilirubin Within Normal Limits (WNL); AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
* If there is childbearing potential, a serum pregnancy test must be negative.
* Patients of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months following the completion of treatment.
* Informed consent has been obtained.

Exclusion Criteria:

* Prior treatment with Taxotere®.
* Concurrent immunotherapy or hormonal therapy for the specific purpose of treatment for the disease. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to enrollment in order for the patient to be eligible to participate in this trial. Continuation of Hormone Replacement therapy is permitted.
* Serious concurrent medical or psychiatric illness, including serious active infection.
* Peripheral neuropathy \> grade 2.
* History of other malignancy within the last 5 years, except for basal cell skin carcinoma.
* The patient is pregnant or nursing.
* Patients with a history of severe hypersensitivity reaction to cisplatin, carboplatin, mannitol, or drugs formulated with Polysorbate 80.
* Secondary debulking for this recurrence.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Every 6 months, to 18 months
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Every 6 months, starting at 12 months to 24 months
measure: Quality of Life
timeFrame: Baseline performed 14 days before first dose, then every other cycle and at study termination
measure: Recurrence-Free Survival
timeFrame: Every 6 months starting at 12 months, to 24 months
measure: Median Overall Survival
timeFrame: Every 6 months starting at 12 months, to 24 months
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Florida Gynecologic Oncology
state: Florida
city: Jupiter
country: United States
facility: Jupiter Medical Center-Gynecology Oncology and Gynecology
state: Florida
city: Orlando
country: United States
facility: Florida Hospital/Gyn/Onc Department
state: Florida
city: Bettendorf
country: United States
facility: Hematology-Onc. Assoc. of The Quad Cities
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Franklin Square Hospital Center/MedStar Health-Section of Hematology/Oncology
state: Maryland
city: Hackensack
country: United States
facility: Cancer Center at Hackensack
state: New Jersey
city: New York
country: United States
facility: Columbia University College of Physicians and Surg
state: New York
city: Asheville
country: United States
facility: Hope: A Woman's Cancer Center
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina/ Division of Gyn Oncology
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center/Gyn Oncology Department
state: North Carolina
city: Durham
country: United States
facility: Duke University/Division of Gynecologic Oncology
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Regional Cancer Center
state: North Carolina
city: Oklahoma City
country: United States
facility: Gynecologic Oncology and Surgery
state: Oklahoma
city: Philadelphia
country: United States
facility: PA Hematology/Oncology Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC-Div of Gyn/Oncology
state: South Carolina
city: Memphis
country: United States
facility: The West Cancer Clinic
state: Tennessee
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
Study officials:
affiliation: Duke University
name: Angeles A Secord, MD
role: STUDY_CHAIR
References:
citation: Alvarez Secord A, Berchuck A, Higgins RV, Nycum LR, Kohler MF, Puls LE, Holloway RW, Lewandowski GS, Valea FA, Havrilesky LJ. A multicenter, randomized, phase 2 clinical trial to evaluate the efficacy and safety of combination docetaxel and carboplatin and sequential therapy with docetaxel then carboplatin in patients with recurrent platinum-sensitive ovarian cancer. Cancer. 2012 Jul 1;118(13):3283-93. doi: 10.1002/cncr.26610. Epub 2011 Nov 9.
citation: Pokrzywinski R, Secord AA, Havrilesky LJ, Puls LE, Holloway RW, Lewandowski GS, Higgins RV, Nycum LR, Kohler MF, Revicki DA. Health-related quality of life outcomes of docetaxel/carboplatin combination therapy vs. sequential therapy with docetaxel then carboplatin in patients with relapsed, platinum-sensitive ovarian cancer: results from a randomized clinical trial. Gynecol Oncol. 2011 Dec;123(3):505-10. doi: 10.1016/j.ygyno.2011.08.015. Epub 2011 Sep 25.
citation: Havrilesky LJ, Pokrzywinski R, Revicki D, Higgins RV, Nycum LR, Kohler MF, Berchuck A, Myers ER, Secord AA. Cost-effectiveness of combination versus sequential docetaxel and carboplatin for the treatment of platinum-sensitive, recurrent ovarian cancer. Cancer. 2012 Jan 15;118(2):386-91. doi: 10.1002/cncr.26199. Epub 2011 May 19.