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A Phase II Study of Sequential Carboplatin, Paclitaxel and Hycamtin in Patients With Previously Untreated Advanced Ovarian Cancer

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer

Thank you

Trial Information

A Phase II Study of Sequential Carboplatin, Paclitaxel and Hycamtin in Patients With Previously Untreated Advanced Ovarian Cancer

OBJECTIVES: I. Evaluate the efficacy of sequential carboplatin, paclitaxel, and topotecan in
terms of disease response, time to progression, survival and progression free survival in
patients with stage IIB, stage III, or stage IV ovarian epithelial cancer. II. Assess the
toxicity of this regimen in this patient population.

OUTLINE: Patients receive carboplatin IV over 30 to 60 minutes on days 1 and 22. Patients
then receive paclitaxel IV over 3 hours on days 43 and 64, then topotecan IV over 30 minutes
daily for 5 days beginning on days 85, 106, 127, and 148. Treatment continues in the absence
of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months
and then every 3 months for 2 years.

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

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian epithelial carcinoma
with greater than 1 cm residual disease at completion of initial surgery Stage IIB, IIIA,
IIIB, IIIC, or IV Measurable disease OR CA 125 greater than 120 units/mL obtained post

PATIENT CHARACTERISTICS: See General Eligibility Criteria

PRIOR CONCURRENT THERAPY: Biological therapy: No prior or concurrent immunotherapy
Chemotherapy: No prior or concurrent chemotherapy Endocrine: No prior or concurrent
hormonal therapy Radiotherapy: No prior radiotherapy No concurrent radiotherapy except to
limited fields (e.g., for palliation of bone pain) Surgery: Diagnostic surgery performed
less than 12 weeks prior to study No concurrent interval debulking Other: At least 30 days
or five half-lives since any prior investigational therapy No other concurrent
investigational therapy --Patients Characteristics-- Age: 18 and over Performance status:
ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 9.0 g/dL
WBC at least 4,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: SGOT and/or SGPT no greater than 2.5 times upper limit of normal
(ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no
greater than 2.5 times ULN (no greater than 5 times ULN if liver and/or bone metastases
present) Renal: Creatine less than 2 times ULN Creatinine clearance at least 50 mL/min
Other: No prior malignancy except basal cell skin carcinoma or carcinoma in situ of the
cervix No uncontrolled infection No other concurrent medical conditions that would prevent
full compliance or expose patient to extreme risk or decreased life expectancy No
concurrent medical condition for which treament with platinum compounds is contraindicated
No history of allergy to compounds related to the drugs used in this study No prior motor
or sensory neurotoxicity grade 2 or worse Not pregnant or nursing Fertile patients must
use effective contraception

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Gordon J.S. Rustin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mount Vernon Cancer Centre at Mount Vernon Hospital


United States: Federal Government

Study ID:




Start Date:

December 1997

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Ovarian Neoplasms