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Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

From date of registration to date of death from any cause

Safety Issue:

No

Principal Investigator

Robert T. Morris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000445432

NCT ID:

NCT00227721

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Sinai-Grace HospitalDetroit, Michigan  48235