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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Carboplatin
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Relapsed ovarian cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Florida Gynecologic Oncology
  • Jupiter Medical Center-Gynecology Oncology and Gynecology
  • Florida Hospital/Gyn/Onc Department
  • Hematology-Onc. Assoc. of The Quad Cities
  • University of Iowa
  • Franklin Square Hospital Center/MedStar Health-Section of Hematology/Oncology
  • Cancer Center at Hackensack
  • Columbia University College of Physicians and Surg
  • Hope: A Woman's Cancer Center
  • University of North Carolina/ Division of Gyn Oncology
  • Carolinas Medical Center/Gyn Oncology Department
  • Duke University/Division of Gynecologic Oncology
  • Forsyth Regional Cancer Center
  • Gynecologic Oncology and Surgery
  • PA Hematology/Oncology Associates
  • Western Pennsylvania Hospital
  • MUSC-Div of Gyn/Oncology
  • The West Cancer Clinic
  • Southwest Regional Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1 - Combination Therapy

Arm 2 - Sequential Therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
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
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
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.
Recurrence-Free Survival
Recurrence-free survival is based on measurable disease using Kaplan-Meier estimates for the intent to treat (ITT) Population who achieved a complete response.
Median Overall Survival

Full Information

First Posted
August 27, 2004
Last Updated
February 5, 2015
Sponsor
Duke University
Collaborators
Aventis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00090610
Brief Title
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

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Aventis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Relapsed ovarian cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - Combination Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Arm 2 - Sequential Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
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
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
Every 6 months, to 18 months
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
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
Time Frame
Every 6 months, starting at 12 months to 24 months
Title
Quality of Life
Description
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.
Time Frame
Baseline performed 14 days before first dose, then every other cycle and at study termination
Title
Recurrence-Free Survival
Description
Recurrence-free survival is based on measurable disease using Kaplan-Meier estimates for the intent to treat (ITT) Population who achieved a complete response.
Time Frame
Every 6 months starting at 12 months, to 24 months
Title
Median Overall Survival
Time Frame
Every 6 months starting at 12 months, to 24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angeles A Secord, MD
Organizational Affiliation
Duke University
Official's Role
Study Chair
Facility Information:
Facility Name
Florida Gynecologic Oncology
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Jupiter Medical Center-Gynecology Oncology and Gynecology
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Florida Hospital/Gyn/Onc Department
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Hematology-Onc. Assoc. of The Quad Cities
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Franklin Square Hospital Center/MedStar Health-Section of Hematology/Oncology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237-3998
Country
United States
Facility Name
Cancer Center at Hackensack
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Columbia University College of Physicians and Surg
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Hope: A Woman's Cancer Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28816
Country
United States
Facility Name
University of North Carolina/ Division of Gyn Oncology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7570
Country
United States
Facility Name
Carolinas Medical Center/Gyn Oncology Department
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232
Country
United States
Facility Name
Duke University/Division of Gynecologic Oncology
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-0001
Country
United States
Facility Name
Forsyth Regional Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Gynecologic Oncology and Surgery
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
PA Hematology/Oncology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
MUSC-Div of Gyn/Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
The West Cancer Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Southwest Regional Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22072307
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.
Results Reference
result
PubMed Identifier
21945310
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.
Results Reference
result
PubMed Identifier
21598242
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.
Results Reference
result

Learn more about this trial

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

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