NCT00003943

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Cancer.

A Phase II Trial of High Dose Paclitaxel, Carboplatin and Topotecan With Peripheral Blood Stem Cell Support in Extensive Stage Small Cell Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have metastatic cancer.

Detailed description

OBJECTIVES: I. Evaluate one year progression free survival, complete response rate, and overall survival in patients with metastatic small cell cancer treated with high dose paclitaxel, carboplatin, and topotecan with peripheral blood stem cell support. II. Assess the safety of this treatment regimen in this patient population. OUTLINE: Patients receive cyclophosphamide IV over 1 hour, followed by paclitaxel IV over 24 hours on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing through the day prior to the last collection day. Peripheral blood stem cells (PBSC) are collected over 3-5 days. Beginning approximately 21 days following mobilization, patients receive paclitaxel IV over 24 hours on day 1, immediately followed by carboplatin IV over 2 hours and topotecan IV over 24 hours on day 2, then G-CSF subcutaneously beginning on day 4 and continuing until blood counts recover. PBSC are reinfused on day 5. Patients receive 1/3 of PBSC with each course. Treatment repeats every 4 weeks for 3 courses in the absence of unacceptable toxicity. Patients are followed at week 8 after treatment, then every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Conditions

• Carcinoma of Unknown Primary
• Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	5 ug/kg
DRUG	carboplatin	AUC 5
DRUG	cyclophosphamide	3 gm/m2
DRUG	paclitaxel	250 mg/m2
DRUG	topotecan hydrochloride	10 mg/m2
PROCEDURE	peripheral blood stem cell transplantation	harvest via apheresis

Timeline

• Start date: 1998-09-01
• Primary completion: 2000-11-01
• Completion: 2003-02-01
• First posted: 2004-05-03
• Last updated: 2013-04-17

Locations

2 sites across 1 country: United States