Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Gynecologic Oncology Group (GOG)

Status and phase: Terminated; Phase 2

Conditions: Primary Peritoneal Cavity Cancer; Ovarian Cancer

Treatments: Drug: paclitaxel

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00023907

GOG-0126N

CDR0000068875

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.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.

Full description

OBJECTIVES:

• Determine the antitumor activity of paclitaxel in patients with recurrent or persistent platinum- and paclitaxel-resistant ovarian epithelial or primary peritoneal cancer.
• Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: Patients receive paclitaxel IV over 1 hour once weekly for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 6-12 months.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed recurrent or persistent ovarian epithelial or primary peritoneal cancer

• Measurable disease

  • At least 1 lesion measured in at least 1 dimension

    • At least 20 mm by conventional techniques OR
    • At least 10 mm by spiral CT scan

• At least 1 target lesion

  • Tumors within a previously irradiated field considered non-target lesions

• Paclitaxel resistant

  • Treatment-free interval of less than 6 months duration after treatment with prior paclitaxel OR
  • Progression during prior paclitaxel-based therapy

• Platinum resistant or refractory

  • Treatment-free interval of less than 6 months duration after treatment with prior platinum OR
  • Progression during prior platinum-based therapy

• Ineligible for higher priority GOG protocol (any active GOG phase III protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active infection requiring antibiotics
• No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No grade 2 or greater neuropathy (sensory and motor)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic or immunologic agents for cancer

Chemotherapy:

• See Disease Characteristics
• At least 3 weeks since prior chemotherapy for cancer and recovered
• Received at least 1 but no more than 2 prior platinum-based chemotherapy regimens containing carboplatin, cisplatin, or other organoplatinum compound for primary or recurrent disease
• Initial treatment may include high-dose therapy, consolidation, or extended therapy
• Received at least 1 prior paclitaxel-based chemotherapy regimen
• No prior paclitaxel or docetaxel with a schedule of less than a 3-week interval between doses
• No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens

Endocrine therapy:

• At least 1 week since prior hormonal therapy for cancer
• Concurrent hormone replacement therapy allowed

Radiotherapy:

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy for cancer and recovered
• No prior radiotherapy to site(s) of measurable disease
• No prior radiotherapy to more than 25% of marrow-bearing areas

Surgery:

• At least 3 weeks since prior surgery for cancer and recovered

Other:

• At least 3 weeks since other prior therapy for cancer
• No prior anticancer treatment that would preclude study
• No concurrent amifostine or other protective reagents