Second-Line Treatment for Patients With Platinum-Sensitive Ovarian Cancer

NCT ID: NCT00090610

Last Updated: 2015-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2009-10-31

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1 - Combination Therapy

Docetaxel 30mg/m2 mg IV on Days 1 and 8, in combination with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

For Arm 1: 30mg/m2 mg IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression combined with carboplatin

For Arm 2: 30mg/m2 IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression followed by carboplatin

Carboplatin

Intervention Type: DRUG

Arm 1: AUC 6 IV on Days 1 and 8, repeated every 21 days for 6 cycles or until disease progression, combined with docetaxel.

Arm 2: AUC 6 IV every 21 days for 6 cycles or until disease progression, following six cycles of treatment with docetaxel

Arm 2 - Sequential Therapy

Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression. Once subjects have completed 6 cycles of docetaxel, they receive carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

For Arm 1: 30mg/m2 mg IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression combined with carboplatin

For Arm 2: 30mg/m2 IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression followed by carboplatin

Carboplatin

Intervention Type: DRUG

Arm 1: AUC 6 IV on Days 1 and 8, repeated every 21 days for 6 cycles or until disease progression, combined with docetaxel.

Arm 2: AUC 6 IV every 21 days for 6 cycles or until disease progression, following six cycles of treatment with docetaxel

Interventions

Docetaxel

For Arm 1: 30mg/m2 mg IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression combined with carboplatin

For Arm 2: 30mg/m2 IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression followed by carboplatin

Intervention Type: DRUG

Carboplatin

Arm 1: AUC 6 IV on Days 1 and 8, repeated every 21 days for 6 cycles or until disease progression, combined with docetaxel.

Arm 2: AUC 6 IV every 21 days for 6 cycles or until disease progression, following six cycles of treatment with docetaxel

Intervention Type: DRUG

Other Intervention Names

Taxotere; Paraplatin

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angeles A Secord, MD

Role: STUDY_CHAIR

Duke University

Locations

Florida Gynecologic Oncology

Fort Myers, Florida, United States

Jupiter Medical Center-Gynecology Oncology and Gynecology

Jupiter, Florida, United States

Florida Hospital/Gyn/Onc Department

Orlando, Florida, United States

Hematology-Onc. Assoc. of The Quad Cities

Bettendorf, Iowa, United States

University of Iowa

Iowa City, Iowa, United States

Franklin Square Hospital Center/MedStar Health-Section of Hematology/Oncology

Baltimore, Maryland, United States

Cancer Center at Hackensack

Hackensack, New Jersey, United States

Columbia University College of Physicians and Surg

New York, New York, United States

Hope: A Woman's Cancer Center

Asheville, North Carolina, United States

University of North Carolina/ Division of Gyn Oncology

Chapel Hill, North Carolina, United States

Carolinas Medical Center/Gyn Oncology Department

Charlotte, North Carolina, United States

Duke University/Division of Gynecologic Oncology

Durham, North Carolina, United States

Forsyth Regional Cancer Center

Winston-Salem, North Carolina, United States

Gynecologic Oncology and Surgery

Oklahoma City, Oklahoma, United States

PA Hematology/Oncology Associates

Philadelphia, Pennsylvania, United States

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

MUSC-Div of Gyn/Oncology

Charleston, South Carolina, United States

The West Cancer Clinic

Memphis, Tennessee, United States

Southwest Regional Cancer Center

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22072307 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21945310 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21598242 (View on PubMed)

Other Identifiers

DUKE UNIVERSITY MEDICAL CENTER

Identifier Type: OTHER

Identifier Source: secondary_id

DUMC03

Identifier Type: -

Identifier Source: secondary_id

Pro00008381

Identifier Type: -

Identifier Source: org_study_id