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

February 5, 2015 updated by: Duke University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Gynecologic Oncology
      • Jupiter, Florida, United States, 33458
        • Jupiter Medical Center-Gynecology Oncology and Gynecology
      • Orlando, Florida, United States, 32804
        • Florida Hospital/Gyn/Onc Department
    • Iowa
      • Bettendorf, Iowa, United States, 52722
        • Hematology-Onc. Assoc. of The Quad Cities
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21237-3998
        • Franklin Square Hospital Center/MedStar Health-Section of Hematology/Oncology
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Cancer Center at Hackensack
    • New York
      • New York, New York, United States, 10032
        • Columbia University College of Physicians and Surg
    • North Carolina
      • Asheville, North Carolina, United States, 28816
        • Hope: A Woman's Cancer Center
      • Chapel Hill, North Carolina, United States, 27599-7570
        • University of North Carolina/ Division of Gyn Oncology
      • Charlotte, North Carolina, United States, 28232
        • Carolinas Medical Center/Gyn Oncology Department
      • Durham, North Carolina, United States, 27710-0001
        • Duke University/Division of Gynecologic Oncology
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Regional Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Gynecologic Oncology and Surgery
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • PA Hematology/Oncology Associates
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC-Div of Gyn/Oncology
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Cancer Clinic
    • Texas
      • Austin, Texas, United States, 78705
        • Southwest Regional Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: 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

Other Names:
  • Taxotere
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

Other Names:
  • Paraplatin
Experimental: 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.
Drug: 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

Other Names:
  • Taxotere
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

Other Names:
  • Paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: Every 6 months, to 18 months

Progression in measurable disease is defined as any of the following: At least a 20% increase in the sum of the longest diameter target lesions; appearance of one or more new lesions; Death due to disease without prior objective documentation of progression; deterioration in health status attributable to the disease requiring a change in therapy without objective documentation of progression

Progression in non-measurable disease according to CA125 levels is defined as any of the following: CA125 that begins in normal range increases to twice the upper limit of normal; CA125 level that begins elevated increases 25% over two previous samples, a 50% increase over three previous samples, or a persistent elevation over 100 U/ml for more than 2 months without a 50% decrease.
Every 6 months, to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: Every 6 months, starting at 12 months to 24 months

Complete response rate plus partial response rate, where: Complete response (CR) is defined as disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart and normalization of elevated CA125 in cases of ovarian cancer; Partial response (PR) for measurable disease is defined >= 30% decrease in the sum of the longest dimensions of all target measurable lesions with no unequivocal progression of non-target lesions as well as no new lesions, with documentation by two disease assessments at least four weeks apart. PR according to CA125 levels is defined as a 50% decrease in CA125 levels where two initial samples were elevated and the sample that shows the 50% is confirmed by a fourth sample 28 days after the prior sample.

OR = CR + PR
Every 6 months, starting at 12 months to 24 months
Quality of Life
Time Frame: Baseline performed 14 days before first dose, then every other cycle and at study termination

Quality of Life was measured using the Trial Outcome Index (TOI) score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) instrument, version 4. The TOI portion of the FACT-O included questions related to Physical well-being (PWB), Social/Family well-being (FWB), and an ovarian cancer specific module (OCS). The PWB score range is from 0-28; the FWB score range is from 0-28; the OCS score range is from 0-44; this gives the TOI a score range from 0-100. (TOI = PWB + FWB + OCS)

With these instruments, a higher score indicates better health-related quality of life.
Baseline performed 14 days before first dose, then every other cycle and at study termination
Recurrence-Free Survival
Time Frame: Every 6 months starting at 12 months, to 24 months
Recurrence-free survival is based on measurable disease using Kaplan-Meier estimates for the intent to treat (ITT) Population who achieved a complete response.
Every 6 months starting at 12 months, to 24 months
Median Overall Survival
Time Frame: Every 6 months starting at 12 months, to 24 months
Every 6 months starting at 12 months, to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Aventis Pharmaceuticals

Investigators

  • Study Chair: Angeles A Secord, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

August 27, 2004

First Submitted That Met QC Criteria

August 30, 2004

First Posted (Estimate)

August 31, 2004

Study Record Updates

Last Update Posted (Estimate)

February 25, 2015

Last Update Submitted That Met QC Criteria

February 5, 2015

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00008381
  • DUKE UNIVERSITY MEDICAL CENTER (Other Identifier: Duke UMC)
  • DUMC03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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