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A Phase I Dose-Finding Study of Oxaliplatin (NSC #266046) Combined With Continuous Infusion Topotecan Hydrochloride as Chemotherapy for Patients With Previously Treated Ovarian Cancer


Phase 1
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

A Phase I Dose-Finding Study of Oxaliplatin (NSC #266046) Combined With Continuous Infusion Topotecan Hydrochloride as Chemotherapy for Patients With Previously Treated Ovarian Cancer


OBJECTIVES:

- Determine the maximum tolerated dose and dose-limiting toxic effects of oxaliplatin and
topotecan in patients with previously treated ovarian epithelial cancer, primary
peritoneal cancer, or fallopian tube cancer.

- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.

- Determine the pharmacokinetics of this regimen in these patients.

- Determine the antitumor activity of this treatment regimen in these patients.

- Determine the correlation between the pharmacokinetic and safety data of this regimen
in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously
on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity. Patients with measurable disease who achieve a
response may receive additional therapy at the discretion of the principal investigator.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin and topotecan until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6
patients experience dose-limiting toxicity.

Patients are followed through day 30.

PROJECTED ACCRUAL: A minimum of 15 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed ovarian epithelial cancer, primary
peritoneal cancer, or fallopian tube cancer

- Prior chemotherapy required

- Measurable or evaluable disease

- No symptomatic, untreated brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- At least 4 months

Hematopoietic:

- WBC greater than 3,000/mm^3

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN) OR

- SGOT no greater than 2.5 times ULN (5 times ULN if liver metastases)

Renal:

- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance at least 50 mL/min

Cardiovascular:

- No uncontrolled symptomatic congestive heart failure

- No unstable angina pectoris

- No uncontrolled cardiac arrhythmia

Other:

- No other active cancer

- No prior allergy to platinum compounds

- No prior allergic reactions to appropriate antiemetics (e.g., serotonin or
antagonists) administered concurrently with study

- No other uncontrolled concurrent illness (e.g., infection)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study
therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Chemotherapy

- No concurrent colony stimulating factors during topotecan administration

Chemotherapy:

- See Disease Characteristics

- No prior high-dose chemotherapy requiring bone marrow or peripheral blood stem cell
transplantation

- At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to whole pelvic field

- At least 2 weeks since prior radiotherapy and recovered

Surgery:

- No unresolved sequelae resulting from prior surgery

Other:

- At least 4 weeks since other prior investigational drug

- No other concurrent investigational agents

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard S. Hochster, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000068275

NCT ID:

NCT00006391

Start Date:

August 2000

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016