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

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Albumin-Bound Paclitaxel; Oxaliplatin; Paclitaxel

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