Phase II study of VIP (Etoposide, Ifosfamide and Cisplatin) in the treatment of invasive thymoma

Originating Group

ECOG E1C93

P.I.: Dr. P. Loehrer

Participating Groups

Objectives

1. To evaluate the objective response rate in extensive thymoma treated with VIP plus G-CSF.
2. To evaluate the duration of remission and survival in patients with extensive disease treated with VIP plus G-CSF.
3. To evaluate the toxicity of the VIP regimen in this population.

Eligibility

1. Histologically confirmed thymoma or thymic carcinoma.
2. Patients must have extensive disease (distant disease, pleural or pulmonary metastases with or without mediatinal disease, or, for patients withprior radiotherapy, distant metastasis or documented progressive disease in site of previous radiotherapy).
3. Patients with de novo limited disease as defined as disease confined to mediastinum and ipsilateral supraclavicular lymph nodes (such that all disease can be confined to a single radiotherapy portal) are not eligible if they are candidates for surgical resection or definitive radiation therapy.
4. Patientsmust have measurable disease with at least 1 bidimensional measurable lesion. Baseline measurements must be contained within 4 weeks prior to registration.
5. Patients must have adequate renal function (serum creatinine < 1.5 x the upper limit of normal, or calculated creatinine clearance >50 ml/min). Baseline measurements must be obtained within 2 weeks prior to registration.
6. Patients must have adequate hepatic function (serum bilirubin < 2.0 mg/dl). Baseline measurements must be obtained within 2 weeks prior to registration.
7. Patients must have adequate bone marrow function (WBC > 4,000/mm3), platelet count > 125,000/mm3). Baseline measurements must be obtained within 2 weeks priorto registration.
8. Patients who are receiving corticosteroids for myasthenia gravis are eligible for this protocol but they should remain on stable dose of corticosteroids after baseline measurements are obtained.
9. Patients must not have received prior systemic chemotherapy.
10. Patients must not have a history of uncontrolled congestive heart failure which would preclude adequate hydration.
11. Patients must have an ECOG performance status of 0, 1 or 2.
12. Patients must not have acute intercurrent complications such as infection or post surgical complications.
13. Patients must not have had a previous malignancy within the previous 5 years except previously treated basal cell carcinoma of the skin or in-situ carcinoma of breast or cervix.
14. Age > 18 years of age.
15. Patients must not be pregnant or lactating.
16. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
17. Patients must have signed written informed consent.

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Comments

Publications

1. Abstract: Loehrer PJ, Jiroutek M, Aisner S, et al. Phase II trial of etoposide, ifosfamide and cisplatin in patients with advanced thymoma or thymic carcinoma: Preliminary results from an ECOG coordinated trial. Proceedings of ASCO, 1998;17:30a.