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PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES


Phase 1
N/A
N/A
Not Enrolling
Female
Brenner Tumor, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mixed Epithelial Carcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Undifferentiated Adenocarcinoma, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

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Trial Information

PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES


PRIMARY OBJECTIVES:

I. Determine the maximum tolerated doses of paclitaxel, cisplatin, and topotecan
administered together with or without filgrastim (G-CSF) in patients with newly diagnosed
advanced ovarian cancer.

II. Describe and quantitate the clinical toxic effects of combination chemotherapy with
paclitaxel, cisplatin, and topotecan with or without G-CSF.

III. Assess preliminary evidence of antitumor activity of this combination chemotherapy in
these patients.

OUTLINE: This is a dose escalation study of topotecan.

Patients receive paclitaxel IV over 3 hours and cisplatin IV on day 1, followed by topotecan
IV over 30 minutes on days 1-3. Patients receive filgrastim (G-CSF) subcutaneously beginning
on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks in the
absence of disease progression or unacceptable toxicity.

Cohorts of 4-6 patients receive escalating doses of topotecan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose limiting toxicities.

Patients are followed as clinically indicated.


Inclusion Criteria:



- Histologically confirmed epithelial ovarian carcinoma

- No borderline ovarian carcinoma

- Stage III/IV disease that has been suboptimally or optimally debulked

- The following histologies are eligible:

- Adenocarcinoma (unspecified)

- Mucinous cystadenocarcinoma

- Clear cell adenocarcinoma

- Serous cystadenocarcinoma

- Endometrioid adenocarcinoma

- Transitional cell carcinoma

- Malignant Brenner's tumor

- Undifferentiated carcinoma

- Mixed epithelial carcinoma

- Extraovarian papillary serous cystadenocarcinoma

- Measurable or evaluable disease

- Performance status - GOG 0-1

- Enabling completion of at least 2 courses of therapy

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

- No myocardial infarction within 6 months

- No congestive heart failure

- No unstable or uncontrolled angina

- No history of cardiac arrhythmia requiring anti-arrhythmia medication

- No uncontrolled hypertension

- No hypersensitivity to E. coli-derived drug preparation

- No active infection

- No sensory neuropathy

- No other malignancies within the past 5 years except nonmelanomatous skin cancer

- No prior chemotherapy

- No prior radiotherapy

- Recovered from any recent surgery

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximally tolerated doses (MTDs) of the combination of paclitaxel, Topotecan, and cisplatin administered without and with G-CSF based on dose-limiting toxicities (DLT) graded according to GOG Common Toxicity Criteria

Outcome Time Frame:

3 weeks

Safety Issue:

Yes

Principal Investigator

Deborah Armstrong

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02251

NCT ID:

NCT00002913

Start Date:

December 1996

Completion Date:

Related Keywords:

  • Brenner Tumor
  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mixed Epithelial Carcinoma
  • Ovarian Mucinous Cystadenocarcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Undifferentiated Adenocarcinoma
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Brenner Tumor
  • Carcinoma
  • Cystadenocarcinoma
  • Carcinoma, Endometrioid
  • Cystadenocarcinoma, Mucinous
  • Cystadenocarcinoma, Serous
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location
Gynecologic Oncology Group of Arizona Phoenix, Arizona  85012