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.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer; Peritoneal Cavity Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: Gemcitabine hydrochloride

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Dearborn, Michigan, United States, 48123-2500
      • Oakwood Cancer Center at Oakwood Hospital and Medical Center
    • Detroit, Michigan, United States, 48201-1379
      • Barbara Ann Karmanos Cancer Institute
  • Ohio
    • Columbus, Ohio, United States, 43210-1240
      • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Northern Virginia Pelvic Surgery Assoc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Taxotere®; Drug: Gemcitabine hydrochloride; 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days; Other Names: Gemzar ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer.	Disease status by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or Gynecological Cancer Intergroup (GCIG) CA-125 criteria was assessed every two cycles from enrollment up to progression, death, or five years (whichever occurred first).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival	Progression-free survival estimated using Kaplan-Meier's product-limit method.	Every two cycles until disease progression or death, assessed up to 5 years

Collaborators and Investigators

• Sponsor: Robert Morris
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Robert T. Morris, MD, Barbara Ann Karmanos Cancer Institute

Publications and helpful links

Helpful Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: September 26, 2005
• First Submitted That Met QC Criteria: September 26, 2005
• First Posted (Estimate): September 28, 2005

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: recurrent ovarian epithelial cancer; peritoneal cavity cancer
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gemcitabine; Docetaxel
• Other Study ID Numbers: CDR0000445432; P30CA022453 (U.S. NIH Grant/Contract); WSU-C-2713