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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Neoplasms, Germ Cell and Embryonal

Treatments

Drug: Oxaliplatin, Paclitaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00611962

EFC_7407

Details and patient eligibility

About

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

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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