Clinical trial NCT00227721: Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer
Official title: Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer
peritoneal cavity cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer.
timeFrame: 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 outcomes:
measure: Progression-free Survival
timeFrame: Every two cycles until disease progression or death, assessed up to 5 years
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: Oakwood Cancer Center at Oakwood Hospital and Medical Center
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
city: Annandale
country: United States
facility: Northern Virginia Pelvic Surgery Assoc
state: Virginia
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Robert T. Morris, MD
role: PRINCIPAL_INVESTIGATOR
References: