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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

September 26, 2005
May 20, 2014
February 2004
December 2014   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: From date of registration to date of death from any cause ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00227721 on ClinicalTrials.gov Archive Site
Progression-free survival [ Time Frame: Every two cycles ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer
Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • 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 ®
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
Interventions:
  • Drug: Docetaxel
  • Drug: Gemcitabine hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00227721
CDR0000445432, P30CA022453, WSU-C-2713
Yes
Robert Morris, M.D., Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Robert T. Morris, MD Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP