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Phase II Evaluation of Oxaliplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer

Phase 2
Not Enrolling
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

Phase II Evaluation of Oxaliplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer

OBJECTIVES: I. Determine the antitumor activity of oxaliplatin by measuring response rate in
patients with recurrent or refractory, platinum resistant ovarian epithelial or primary
peritoneal carcinoma who have failed on higher priority treatment protocols. II. Determine
the nature and degree of toxicity of this drug in this patient population.

OUTLINE: Patients receive oxaliplatin IV over 2 hours. Treatment continues every 21 days for
a maximum of 9 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 12-14

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory ovarian
epithelial or primary peritoneal carcinoma Bidimensionally measurable disease Ascites and
pleural effusions are not considered measurable disease Sonography acceptable provided
lesions are clearly defined on initial examination and bidimensionally measurable Must
have had 1 prior platinum based chemotherapy regimen containing carboplatin, cisplatin, or
another organoplatinum compound for management of primary disease Initial treatment may
include high dose therapy, consolidation, or extended therapy administered after surgical
or nonsurgical assessment No additional cytotoxic chemotherapy for management of recurrent
or persistent disease, including retreatment with initial chemotherapy regimens Must be
considered platinum resistant or refractory Treatment free interval of less than 6 months
following platinum or progression during platinum based therapy No known brain metastases
Must not be eligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least lower limit of normal 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 Cardiovascular: No symptomatic
congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not
pregnant or nursing Fertile patients must use effective contraception No active infection
requiring antibiotics No evidence of preexisting peripheral sensory neuropathy greater
than grade 1, including residual neuropathy attributed to prior chemotherapy and other
chronic conditions (e.g., diabetes, venous stasis, and carpal tunnel syndrome) No history
of allergy to platinum compounds or to antiemetics appropriate for administration in
conjunction with protocol directed chemotherapy No other uncontrolled concurrent illness
(e.g., ongoing or active infection) No other malignancy within the past 5 years except
nonmelanoma skin cancer and no other prior malignancy whose prior cancer treatment
contraindicates this protocol therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy
At least 3 weeks since prior immunotherapy No concurrent colony stimulating factors (CSFs)
during first course of therapy At least 24 hours since prior CSFs during subsequent
courses of therapy Chemotherapy: See Disease Characteristics No prior oxaliplatin No more
than 1 prior chemotherapy regimen If initial therapy did not include paclitaxel, a second
regimen including paclitaxel is allowed At least 3 weeks since prior chemotherapy and
recovered Endocrine therapy: At least 1 week since prior hormonal therapy directed at
malignant tumor Concurrent continuation of hormone replacement therapy allowed
Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior
radiotherapy to sites of measurable disease used on this trial No prior radiotherapy to
greater than 25% of bone marrow Surgery: At least 3 weeks since prior surgery and
recovered Other: No other concurrent investigational agents No concurrent antiretroviral
therapy (HAART)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Paula M. Fracasso, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

July 2004

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial



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