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A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV


OBJECTIVES:

- Determine the tolerability and toxicity of paclitaxel, carboplatin, and gemcitabine in
patients with previously untreated stage IC-IV ovarian epithelial, fallopian tube, or
peritoneal carcinoma.

- Determine the response rate of patients treated with this regimen.

- Determine the time to progression and overall survival of patients treated with this
regimen.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and
gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the
absence of disease progression or unacceptable toxicity.

Patients are followed at 3 and 6 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IC-IV ovarian epithelial, fallopian tube, or
peritoneal carcinoma

- No tumors of low-malignant potential (borderline tumors)

- No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2 OR

- Karnofsky 70-100%

Life expectancy:

- At least 6 months

Hematopoietic:

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin greater than 10 g/dL

Hepatic:

- Bilirubin no greater than 2 times upper limit of normal

Renal:

- Glomerular filtration rate at least 60 mL/min

Cardiovascular:

- No history of congestive heart failure (New York Heart Association class III or IV
heart disease) even if medically controlled

- No myocardial infarction within the past 6 months

- No history of atrial or ventricular arrhythmias

Neurologic:

- No history of seizure disorder

- No history of CNS disorder

- No pre-existing motor or sensory neuropathy or symptoms grade 2 or greater

Other:

- No severe concurrent infection

- No prior hypersensitivity reaction to products containing Cremophor EL or compounds
chemically related to carboplatin, paclitaxel, or gemcitabine

- No complete bowel obstruction

- No other concurrent severe medical problems that would preclude study

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent immunotherapy

- No concurrent WBC transfusions

Chemotherapy:

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy except replacement therapy or steroid antiemetics

Radiotherapy:

- No prior radiotherapy

- No concurrent radiotherapy

Surgery:

- No more than 6 weeks since prior definitive surgery

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of tolerability and toxicity of the combination therapy with paclitaxel, carboplatin and gemcitabine (P-C-G) in first line treatment of ovarian cancer patients. Evaluation of Drop-out rate due to toxicity

Outcome Description:

The decision level is reached, when the lower exact 95% confidence limit of the observed proportion is higher than the upper exact 95% confidence limit of the historical proportion, which corresponds to a power of 0.5 applying a significance level of 0.05

Outcome Time Frame:

Based on decision level

Safety Issue:

Yes

Principal Investigator

Andreas du Bois, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Dr. Horst-Schmidt-Kliniken

Authority:

United States: Federal Government

Study ID:

CDR0000069242

NCT ID:

NCT00031954

Start Date:

August 2001

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage II ovarian epithelial cancer
  • stage I ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

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