Neoadjuvant Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer-Prospective, Randomized Phase II Clinical Trial (PRIMOVAR-1)

University Hospital Bonn (UKB)

Status and phase: Unknown; Phase 2

Conditions: Ovarian Neoplasms

Treatments: Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00551577

PRIMOVAR-1

Details and patient eligibility

About

The purpose of this study is to evaluate response to neoadjuvant chemotherapy by imaging and observation of anatomical and biological indicators (i.e. ascites or continuous measurement of tumor marker CA 125). Furthermore the optimal number of preoperative administered cycles of combination chemotherapy with carboplatin and docetaxel should be determined.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histological confirmed ovarian neoplasm
• Figo stage IIIC (2cm extrapelvic disease) or Figo IV
• more than 500 ml ascites volume (measured by sonography)
• age > 18 years old
• ECOG <= 2
• adequate hepatological, renal and haematological function
• informed consent

Exclusion criteria

• concomitant or previous malignant diseases
• debulking procedures on initial surgical approach
• existing peripheral sensoric neuropathy >= grade 2
• acute infections
• mental disorders, cerebral metastasis
• bowel obstruction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

A1

Active Comparator group

Description:

3 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 3 cycles of Carboplatin/Docetaxel (3-weekly) postoperative

Treatment:

Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)

Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)

A2

Experimental group

Description:

2 cycles of Carboplatin/Docetaxel (3-weekly) preoperative and 4 cycles of Carboplatin/Docetaxel (3-weekly) postoperative

Treatment:

Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)

Procedure: neoadjuvant chemotherapy (Carboplatin/Docetaxel)