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

Primary Purpose

Carcinoma of Unknown Primary, Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
carboplatin
cyclophosphamide
paclitaxel
topotecan hydrochloride
peripheral blood stem cell transplantation
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma of Unknown Primary focused on measuring extensive stage small cell lung cancer, newly diagnosed carcinoma of unknown primary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed small cell carcinoma Any primary site or unknown primary site Extensive or metastatic disease Lung primaries must have at least one of the following: Contralateral hilar adenopathy Contralateral supraclavicular adenopathy Malignant pleural effusion Distant metastases No brain metastases or CNS involvement Stable or responding disease to prior standard therapy allowed Measurable or evaluable disease prior to standard therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Transaminases no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min No overt renal failure Cardiovascular: Ejection fraction at least 45% No myocardial infarction within past 6 months No congestive heart failure No significant cardiac arrhythmia No poorly controlled hypertension Pulmonary: FEV1 and DLCO at least 45% predicted No severe pulmonary disease Other: HIV negative No AIDS No other prior or concurrent malignancies within the past 5 years except basal or squamous cell skin cancer No severe medical illness (e.g., active peptic ulcer disease or brittle or uncontrolled insulin dependent diabetes) No severe or uncontrolled psychiatric illness (e.g., severe depression) No history of drug abuse Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception 3 months prior to, during and 3 months after study No hypersensitivity to E. coli derivatives PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: 2 prior courses of standard therapy of etoposide and a platinum analog required No other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 3 weeks since prior major surgery

Sites / Locations

  • Johns Hopkins Oncology Center
  • Fox Chase Cancer Center

Outcomes

Primary Outcome Measures

Determine the one year progression-free survival

Secondary Outcome Measures

Overall survival; safety of regimen; CR rate; lab correlates; pharmacokinetics

Full Information

First Posted
November 1, 1999
Last Updated
April 16, 2013
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003943
Brief Title
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Cancer.
Official Title
A Phase II Trial of High Dose Paclitaxel, Carboplatin and Topotecan With Peripheral Blood Stem Cell Support in Extensive Stage Small Cell Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
November 2000 (Actual)
Study Completion Date
February 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma of Unknown Primary, Lung Cancer
Keywords
extensive stage small cell lung cancer, newly diagnosed carcinoma of unknown primary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Description
5 ug/kg
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
AUC 5
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
3 gm/m2
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
250 mg/m2
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Intervention Description
10 mg/m2
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Description
harvest via apheresis
Primary Outcome Measure Information:
Title
Determine the one year progression-free survival
Time Frame
one year
Secondary Outcome Measure Information:
Title
Overall survival; safety of regimen; CR rate; lab correlates; pharmacokinetics
Time Frame
five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed small cell carcinoma Any primary site or unknown primary site Extensive or metastatic disease Lung primaries must have at least one of the following: Contralateral hilar adenopathy Contralateral supraclavicular adenopathy Malignant pleural effusion Distant metastases No brain metastases or CNS involvement Stable or responding disease to prior standard therapy allowed Measurable or evaluable disease prior to standard therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Transaminases no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min No overt renal failure Cardiovascular: Ejection fraction at least 45% No myocardial infarction within past 6 months No congestive heart failure No significant cardiac arrhythmia No poorly controlled hypertension Pulmonary: FEV1 and DLCO at least 45% predicted No severe pulmonary disease Other: HIV negative No AIDS No other prior or concurrent malignancies within the past 5 years except basal or squamous cell skin cancer No severe medical illness (e.g., active peptic ulcer disease or brittle or uncontrolled insulin dependent diabetes) No severe or uncontrolled psychiatric illness (e.g., severe depression) No history of drug abuse Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception 3 months prior to, during and 3 months after study No hypersensitivity to E. coli derivatives PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: 2 prior courses of standard therapy of etoposide and a platinum analog required No other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 3 weeks since prior major surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell J. Schilder, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States

12. IPD Sharing Statement

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

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