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

NCT00090610 | Completed Phase 2 Results DMC

• 3 other identifiers: Pro00008381DUKE UNIVERSITY MEDICAL CENTERDUMC03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Ovarian Cancer

Keywords

Relapsed ovarian cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Every 6 months, to 18 months

Secondary Outcomes (4)

• Objective Response Rate

  Every 6 months, starting at 12 months to 24 months

• Quality of Life

  Baseline performed 14 days before first dose, then every other cycle and at study termination

• Recurrence-Free Survival

  Every 6 months starting at 12 months, to 24 months

• Median Overall Survival

  Every 6 months starting at 12 months, to 24 months

Study Arms (2)

Arm 1 - Combination Therapy

EXPERIMENTAL

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; Drug: Carboplatin

Arm 2 - Sequential Therapy

EXPERIMENTAL

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; Drug: Carboplatin

Interventions

Docetaxel 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

Also known as: Taxotere

Arm 1 - Combination Therapy; Arm 2 - Sequential Therapy

Carboplatin 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

Also known as: Paraplatin

Arm 1 - Combination Therapy; Arm 2 - Sequential Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Aventis Pharmaceuticals: collaborator

Study Sites (19)

Florida Gynecologic Oncology

Fort Myers, Florida, 33901, United States

Location

Jupiter Medical Center-Gynecology Oncology and Gynecology

Jupiter, Florida, 33458, United States

Location

Florida Hospital/Gyn/Onc Department

Orlando, Florida, 32804, United States

Location

Hematology-Onc. Assoc. of The Quad Cities

Bettendorf, Iowa, 52722, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

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

Baltimore, Maryland, 21237-3998, United States

Location

Cancer Center at Hackensack

Hackensack, New Jersey, 07601, United States

Location

Columbia University College of Physicians and Surg

New York, New York, 10032, United States

Location

Hope: A Woman's Cancer Center

Asheville, North Carolina, 28816, United States

Location

University of North Carolina/ Division of Gyn Oncology

Chapel Hill, North Carolina, 27599-7570, United States

Location

Carolinas Medical Center/Gyn Oncology Department

Charlotte, North Carolina, 28232, United States

Location

Duke University/Division of Gynecologic Oncology

Durham, North Carolina, 27710-0001, United States

Location

Forsyth Regional Cancer Center

Winston-Salem, North Carolina, 27103, United States

Location

Gynecologic Oncology and Surgery

Oklahoma City, Oklahoma, 73112, United States

Location

PA Hematology/Oncology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

MUSC-Div of Gyn/Oncology

Charleston, South Carolina, 29425, United States

Location

The West Cancer Clinic

Memphis, Tennessee, 38120, United States

Location

Southwest Regional Cancer Center

Austin, Texas, 78705, United States

Location

Related Publications (3)

• 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.

  PMID: 22072307 RESULT

• 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.

  PMID: 21945310 RESULT

• 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.

  PMID: 21598242 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Angeles Alvarez Secord, Director of Gynecologic Oncology Clinical Trials
• Organization: Duke University Medical Center

secor002@mc.duke.edu

919-684-3765

Study Officials

• Angeles A Secord, MD

  Duke University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2004
• First Posted: August 31, 2004
• Study Start: October 1, 2003
• Primary Completion: March 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 25, 2015
• Results First Posted: February 4, 2013

Record last verified: 2012-12

Locations

US (19)