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Second-Line Treatment for Patients With Platinum-Sensitive Ovarian Cancer
This study is currently recruiting participants.
Verified by Duke University, June 2007
Sponsored by: Duke University
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00090610
  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: Taxotere®
Drug: Carboplatin
Phase III

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Carboplatin Docetaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Phase III Comparative Study to Compare the Efficacy and Safety of Taxotere®/Carboplatin Combination Therapy Versus Sequential Therapy With Taxotere® Then Carboplatin as Second-Line Treatment of Patients With Relapsed, Platinum-Sensitive Ovarian Cancer

Further study details as provided by Duke University:

Estimated Enrollment: 250
Study Start Date: October 2003
Estimated Study Completion Date: October 2005
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 CA 125 < 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.
  • 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090610

Contacts
Contact: Amy Evans, BS, MT 910-772-6718 amy.evans@wilm.ppdi.com
Contact: Pat Wood, RN 910-772-7553 patricia.wood@wilm.ppdi.com

  Show 29 Study Locations
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Angeles A Secord, MD Duke University
  More Information

Study ID Numbers: DUMC03, DUKE UNIVERSITY MEDICAL CENTER, CLINICAL STUDY PROTOCOL
Study First Received: August 27, 2004
Last Updated: June 5, 2007
ClinicalTrials.gov Identifier: NCT00090610  
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Relapsed ovarian cancer

Study placed in the following topic categories:
Docetaxel
Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Carboplatin
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009