Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer

Ovarian Endometrioid Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002913
• Other study ID #: NCI-2012-02251
• Secondary ID: GOG-9602U10CA027
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: January 23, 2013
• Start date: December 1996

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase I trial to study the effectiveness of paclitaxel, cisplatin, and topotecan with or without filgrastim in treating patients who have newly diagnosed stage III or stage IV epithelial ovarian cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• paclitaxel
Given IV
• cisplatin
Given IV
• topotecan hydrochloride
Given IV

Biological:
• filgrastim
Given SC

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group of Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		3 weeks	Yes
Secondary	Overall survival		Up to 10 years	No
Secondary	Progression-free survival		Up to 10 years	No