Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Phase II Trial of Topotecan and Paclitaxel in Previously Treated Patients With Relapsed Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003281
• Other study ID #: NCCTG-972051
• Secondary ID: CDR0000066190
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 12, 2016
• Start date: April 1998
• Est. completion date: March 2006

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or refractory small cell lung cancer.

Description:

OBJECTIVES:

• Determine the toxicity of combination topotecan and paclitaxel in previously treated patients with small cell lung cancer.

• Determine the response rate and survival in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to length of time since prior treatment (less than 3 months (stratum A) vs 3 months or more (stratum B)). Stratum A closed to accrual effective 06/20/2000.

Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3. Courses repeat every 4 weeks.

Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression. Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment. Patients who achieve complete remission receive a maximum of 6 courses of treatment. Patients may then undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at the attending physician.

Patients are followed every 3 months for 2 years and then at 3 years after study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Stratum A (less than 3 months since prior therapy) closed to accrual effective 06/20/2000)

• Histologically or cytologically confirmed recurrent or refractory small cell lung cancer

• Only 1 prior regimen allowed (an alternating regimen with cyclophosphamide/doxorubicin/vincristine and etoposide/cisplatin is acceptable)

• No mixed histology

• Measurable or evaluable disease that has not been in the field of prior radiotherapy

• No uncontrolled CNS metastases (treated CNS metastases eligible)

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Hematopoietic:

• Absolute neutrophil count at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR

• Direct bilirubin normal

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No unstable angina pectoris

• No uncontrolled congestive heart failure

• No myocardial infarction within the past 3 months

Other:

• No uncontrolled infections

• No other concurrent malignancy except skin cancer or localized prostate cancer

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No prior topoisomerase I inhibitor (e.g., topotecan or irinotecan) or taxane (e.g., paclitaxel or docetaxel)

• At least 3 months since other prior chemotherapy

Radiotherapy:

• See Disease Characteristics

• At least 2 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery:

• At least 3 weeks since any prior major surgery

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• paclitaxel

• topotecan hydrochloride

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
United States	Medcenter One Health System	Bismarck	North Dakota
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Duluth	Duluth	Minnesota
United States	Altru Health Systems	Grand Forks	North Dakota
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CentraCare Health Plaza	Saint Cloud	Minnesota
United States	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Dy GK, Jett JR, Geoffroy FJ, Krewer KD, Tazelaar H, Maurer M, Rowland K, Mailliard J, Krook J, Dakhil S, Kutteh L, Kugler J, Wender D. Topotecan and paclitaxel in previously treated patients with relapsed small cell lung cancer: phase II trial of the Nort — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate		Up to 5 years	No
Secondary	survival		Up to 5 years	No