Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Morris, M.D., Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00227721
First received: September 26, 2005
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with relapsed or refractory ovarian epithelial or peritoneal cancer.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: Docetaxel
Drug: Gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From date of registration to date of death from any cause ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Every two cycles ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 2004
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel & Gemcitabine hydrochloride
Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle
Drug: Docetaxel
40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days
Other Name: Taxotere®
Drug: Gemcitabine hydrochloride
800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days
Other Name: Gemzar ®

Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate in patients with platinum-sensitive or -resistant relapsed or refractory ovarian epithelial or peritoneal cavity cancer treated with gemcitabine and docetaxel.

Secondary

  • Determine the toxicity of this regimen in these patients.
  • Determine the overall survival of patients treated with this regimen.
  • Determine the time to treatment failure and progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with a platinum-containing regimen (platinum-resistant disease vs platinum-sensitive disease).

Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 3 additional courses beyond CR (≥ 6 total courses of treatment).

PROJECTED ACCRUAL: Approximately 36-62 patients (19-29 for stratum I [platinum-resistant disease] and 17-33 for stratum II [platinum-sensitive disease]) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial or peritoneal cavity cancer
  • Relapsed or refractory disease after prior first-line therapy with a platinum-containing regimen

    • Platinum-sensitive or -resistant disease

      • Platinum resistance is defined as relapsed or progressive disease within 6 months after completion of a platinum-containing regimen
  • Measurable or evaluable disease

    • Evaluable disease is defined as CA 125 > 70 U/mL that has doubled from a baseline determination confirmed by ≥ 2 separate blood samples taken > 4 weeks apart OR other evidence demonstrating progressive disease after initial treatment regimen

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL

Hepatic

  • Bilirubin normal
  • Meets 1 of the following criteria:

    • AST or ALT normal AND alkaline phosphatase (AP) ≤ 5 times upper limit of normal (ULN)
    • AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN
    • AST or ALT ≤ 5 times ULN AND AP normal

Renal

  • Creatinine clearance > 30 mL/min
  • Creatinine < 2.5 mg/dL

Cardiovascular

  • No congestive heart failure
  • No second or third degree heart block
  • No myocardial infarction within the past 3 months

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No peripheral neuropathy > grade 1
  • No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix
  • No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • Prior paclitaxel allowed
  • No more than 1 prior chemotherapy regimen

    • First-line platinum-based chemotherapy followed by consolidation therapy in the setting of a clinical and serologic complete response is considered 1 regimen
  • No prior gemcitabine or docetaxel

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered

Surgery

  • Not specified

Other

  • More than 28 days since prior and no other concurrent investigational drugs for this cancer
  • No other concurrent treatment or alternative therapy for this cancer
  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: NCT00227721

Locations
United States, Michigan
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
United States, Virginia
Northern Virginia Pelvic Surgery Assoc
Annandale, Virginia, United States, 22003
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Robert T. Morris, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Robert Morris, M.D., Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00227721     History of Changes
Other Study ID Numbers: CDR0000445432, P30CA022453, WSU-C-2713
Study First Received: September 26, 2005
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:
recurrent ovarian epithelial cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Docetaxel
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014