Clinical trial NCT00964626: Paclitaxel and Cisplatin as First-Line Treatment for Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer
Official title: A Phase II Study of Efficacy and Safety of Paclitaxel and Cisplatin Every 2 Weeks as the First-line Treatment of Patients With Ovarian Cancer Stage Ic-IV.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: stage IA ovarian epithelial cancer
stage IB ovarian epithelial cancer
stage IC ovarian epithelial cancer
stage IIA ovarian epithelial cancer
stage IIB ovarian epithelial cancer
stage IIC ovarian epithelial cancer
stage IIIA ovarian epithelial cancer
stage IIIB ovarian epithelial cancer
stage IIIC ovarian epithelial cancer
stage IV ovarian epithelial cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-08-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving paclitaxel together with cisplatin as first-line therapy and to see how well it works in treating patients with stage I, stage II, stage III, or stage IV ovarian epithelial cancer.

Detailed description: OBJECTIVES:

* To investigate the efficacy and safety of paclitaxel and cisplatin as first-line chemotherapy in patients with stage IC-IV ovarian epithelial cancer.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV and cisplatin IV once every 2 weeks. Treatment repeats every 2 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed epithelial adenocarcinoma of the ovary

  * Stage IC-IV disease
* No known or clinical evidence of brain metastasis

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Hemoglobin must be ≥ 90 g/L
* ANC ≥ 2 x 10\^9/L
* Platelet count ≥ 100 x10\^9/L
* Serum creatinine ≤ 115 μmol/L
* Total bilirubin ≤ 25 μmol/L
* Not pregnant or nursing
* No other serious disease which could affect protocol compliance and results
* No other prior malignancy within the past 5 years except for curatively treated carcinoma in situ of the cervix or squamous carcinoma of the skin
* No peripheral neuropathy ≥ CTCAE version 3.0 grade 2
* No known hypersensitivity to any of the study drugs or their excipients
* No drug addiction or alcoholism
* No disorder which leads to the condition that contraindicates the use of the investigational drugs, or that may affect the patient's compliance with the study requirements

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy for ovarian cancer

Primary outcomes:
measure: Progression-free survival
Secondary outcomes:
measure: Overall survival
measure: Objective response rate (complete and partial remission in patients with measurable disease)
measure: Toxicity
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian Academy of Medical Sciences Cancer Research Center
Study officials:
affiliation: Russian Academy of Medical Sciences
name: Sergei A. Tjulandin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: