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

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00090610
First received: August 27, 2004
Last updated: July 11, 2014
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Ovarian Cancer
Drug: Docetaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: Every 6 months, to 18 months ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: Every 6 months, starting at 12 months to 24 months ] [ Designated as safety issue: No ]

    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


  • Quality of Life [ Time Frame: Baseline performed 14 days before first dose, then every other cycle and at study termination ] [ Designated as safety issue: No ]

    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.


  • Duration of Tumor Response [ Time Frame: Every 6 months starting at 12 months, to 24 months ] [ Designated as safety issue: No ]
  • Median Survival [ Time Frame: Every 6 months starting at 12 months, to 24 months ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: October 2003
Study Completion Date: October 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Paraplatin

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090610

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

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00090610     History of Changes
Other Study ID Numbers: Pro00008381, DUKE UNIVERSITY MEDICAL CENTER, DUMC03
Study First Received: August 27, 2004
Results First Received: November 21, 2012
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:
Relapsed ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Docetaxel
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014