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

NCT ID: NCT00611962

Last Updated: 2008-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-31
• Study Completion Date: 2004-03-31

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

Conditions

Neoplasms, Germ Cell and Embryonal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Oxaliplatin, Paclitaxel

Oxaliplatin was provided in clear glass vials sealed with a rubber stopper and an aluminum seal with a flip-off cover. Each vial contained 50 or 100 mg of active ingredient with 450 or 900 mg, respectively, of lactose monohydrate as excipient

Paclitaxel was supplied as single dose vials of 30 mg/5 mL or 100 mg/17 mL.

Intervention Type: DRUG

Other Intervention Names

Eloxatin®, Taxol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Nathalie Billon

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Lyon, , France

Countries

France

Other Identifiers

EFC_7407

Identifier Type: -

Identifier Source: org_study_id