Phase II Study of Oxaliplatine-Paclitaxel in Patients With Metastatic Germ Cell Tumor Refractory to Cisplatin

Phase 2

Completed

• Conditions: Neoplasms, Germ Cell and Embryonal

• Registration Number: NCT00611962
• Lead Sponsor: Sanofi

Brief Summary

To evaluate the efficacy of the oxaliplatin-paclitaxel combination i.e. evaluation of tumor response rate using World Health Organization/Union Internationale Contre le Cancer (WHO/UICC) and Indianapolis tumor marker (human chorionic gonadotropin \[hCG\], alpha fetoprotein \[AFP\]) criteria in metastatic germ cell cancer patients

Detailed Description

Not available

Study Timeline

• Study Start: 2000-12
• Study Completion: 2004-03
• Status Verified: 2008-01
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-01-28
• Last Update Submitted: 2008-01-28
• Study First Posted: 2008-02-11
• Last Update Posted: 2008-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Histologically proven germ cell cancer: gonadal (including ovarian) or extragonadal, seminomatous or non seminomatous, or clinical presentation of a GCT with elevated AFP level and/or hCG level (> or =to 100 x ULN) when a biopsy was not available
• Metastatic GCT patients:
• Progression disease defined as > 10% increase in hCG and/or AFP markers (and/or documented progressive disease [PD]) during a platinum-based chemotherapy or less than 6 months after the last cycle (in the case of growing non seminomatous tumor, without increased markers, a histological documentation of malignant tumor was required, to exclude growing mature teratoma)
• At least 1 prior line of chemotherapy containing CDDP + etoposide; (prior regimen with high dose chemotherapy and hematopoietic stem cell support was permitted)
• Eastern Cooperative Oncology Group PS (ECOG PS) grade < or =to 2
• At least 1 bidimensionally measurable lesion by imaging (CT scan) of > or =to 20 mm outside an irradiated area OR significantly increased tumor markers > 2 x ULN (on > or =to 2 consecutive tests, even in the absence of measurable lesions)
• Age > or =to 18
• Adequate bone marrow reserve
• Neutrophil count > or =to 1500/mm3
• Platelets > or =to 100,000/mm3
• Renal function:Creatinine < 3 x ULN
• Liver function:Transaminases < or =to 2.5 x ULN, total bilirubin < 1.5 x ULN (if liver metastases, transaminases < or =to 5 x ULN)
• Laboratory values obtained in the week preceding study entry
• Neurosensory < or =to grade 1 NCI CTC
• Signed informed consent obtained prior to all study procedures

Exclusion Criteria

• Concomitant high-dose steroids (except for antiemetic prophylaxis)
• Pregnancy, breast-feeding or absence of contraception in sexually active patients
• Prior treatment with oxaliplatin or taxanes
• History of second malignancy, except for cured non melanoma skin cancer or excised in situ cervical carcinoma
• Symptomatic cerebral and/or leptomeningeal metastasis (irradiated brain metastases not requiring corticosteroid treatment were allowed)
• Treatment with another experimental drug or anticancer agent or participation in another clinical study within 30 days prior to study
• Other serious illness or uncontrolled infection
• Psychological, social or geographical situation preventing regular follow-up
• Primary tumor in brain/central nervous system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluate efficacy of oxaliplatin-paclitaxel combination using established criteria in metastatic germ cell cancer patients	during the study conduct

Secondary Outcome Measures

Name	Time	Method
Evaluate safety, and toxicity using established criteria,specific neurotoxicity scales, serious adverse events (SAEs) and treatment withdrawals	During the study conduct

Trial Locations

Locations (1)

Sanofi-Aventis; 🇫🇷 Lyon, France