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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: topotecan hydrochloride; Drug: paclitaxel; Radiation: radiation therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003281

NCCTG-972051

CDR0000066190 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

topotecan + paclitaxel + radiotherapy

Experimental group

Description:

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.

Treatment:

Drug: paclitaxel

Radiation: radiation therapy

Drug: topotecan hydrochloride