Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

AGO Study Group

Status and phase: Completed; Phase 2

Conditions: Primary Peritoneal Cavity Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: carboplatin; Drug: paclitaxel; Drug: gemcitabine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00031954

EU-20146

AGOSG-OVAR-8

AGO-OVAR 8

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IC, stage IIB, stage III, or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer that has not been previously treated.

Full description

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.

Enrollment: 105 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)