Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: topotecan hydrochloride; Radiation: radiation therapy; Drug: paclitaxel; Drug: etoposide; Biological: filgrastim; Drug: carboplatin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00033696

CDR0000069313 (Registry Identifier)

CALGB-30002

U10CA031946 (U.S. NIH Grant/Contract)

CLB-30002

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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.

Full description

OBJECTIVES:

• Determine the complete and overall response rates in patients with limited stage small cell lung cancer treated with induction chemotherapy comprising paclitaxel, topotecan, and etoposide followed by consolidation chemoradiotherapy.
• Determine the toxicity of this regimen in these patients.
• Determine the overall and failure-free survival of patients treated with this regimen.
• Determine the overall (partial and complete) response rate in patients treated with this induction chemotherapy regimen.

OUTLINE: This is a multicenter study.

• Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover.
• Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks.

Patients with rapid disease progression discontinue study therapy.

Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 10 months.

Enrollment: 65 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed small cell lung cancer

  • Limited stage defined as disease restricted to one hemithorax with regional lymph node metastases including hilar, ipsilateral, and contralateral mediastinal lymph nodes

• Measurable disease

  • At least 20 mm by conventional techniques OR

  • At least 10 mm by spiral CT scan

  • Lesions not considered measurable include the following:

    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural/pericardial effusion
    • Abdominal masses not confirmed and followed by imaging techniques
    • Cystic lesions
    • Tumor lesions in a previously irradiated area

• No clinically suspected or confirmed supraclavicular lymph node metastases

• No pleural effusions visible on plain chest radiographs, regardless of cytology

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm3
• Platelet count at least 100,00/mm3

Hepatic:

• Bilirubin less than 1.5 mg/dL
• SGOT less than 2 times upper limit of normal (ULN)

Renal:

• Creatinine no greater than ULN
• Creatinine clearance no greater than 150 mL/min for men or 130 mL/min for women

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other currently active malignancy except non-melanoma skin cancer
• Patients must have completed therapy for any other malignancy and be considered to be at less than 30% risk of relapse

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent filgrastim (G-CSF) during consolidation therapy

Chemotherapy:

• No prior chemotherapy for small cell lung cancer
• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy except:

  • Steroids for adrenal failure
  • Hormones for non-disease-related conditions (e.g., insulin for diabetes)
  • Intermittent use of dexamethasone as an antiemetic or as an adjunct to prophylactic cranial irradiation

Radiotherapy:

• See Disease Characteristics
• No prior chest radiotherapy

Surgery:

• Not specified

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

65 participants in 1 patient group

chemotherapy + radiation therapy

Experimental group

Description:

Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

Treatment:

Biological: filgrastim

Drug: paclitaxel

Drug: carboplatin

Drug: etoposide

Radiation: radiation therapy

Drug: topotecan hydrochloride