Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: karenitecin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00010218

CLB-30004

U10CA031946 (U.S. NIH Grant/Contract)

CALGB-30004

CDR0000068456 (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.

PURPOSE: Phase II trial to study the effectiveness of karenitecin in treating patients who have relapsed or refractory non-small cell lung cancer

Full description

OBJECTIVES:

• Determine the response rate and duration of response in patients with relapsed or refractory non-small cell lung cancer treated with karenitecin as salvage chemotherapy.
• Determine the effect of prior response to chemotherapy on response to this drug in these patients.
• Determine survival and failure-free survival of patients treated with this drug.
• Determine the toxicity profile of this drug in these patients.

OUTLINE: Patients are stratified according to response to prior chemotherapy (relapsed vs refractory).

Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 6 courses may receive 2 additional courses beyond best response.

Patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: A minimum of 45 patients (25 for stratum I and 20 for stratum II) will be accrued for this study within 12 months.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed relapsed or refractory non-small cell lung carcinoma (NSCLC)

  • Squamous cell carcinoma
  • Basaloid carcinoma
  • Adenocarcinoma
  • Bronchoalveolar carcinoma
  • Adenosquamous cell carcinoma
  • Large cell carcinoma
  • Large cell neuroendocrine carcinoma
  • Giant cell carcinoma
  • Sarcomatoid carcinoma
  • Non-small cell carcinoma not otherwise specified

• Histologic or cytologic documentation of recurrence required if disease previously completely resected

• Must have had only 1 prior chemotherapy regimen, including adjuvant or neoadjuvant therapy for NSCLC

• At least 1 unidimensionally measurable lesion

  • At least 20 mm with conventional techniques OR

  • At least 10 mm with spiral CT scan

  • Lesions that are 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

• Controlled CNS metastases allowed if patient is neurologically stable and off steroids

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm3
• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

Renal:

• Creatinine no greater than upper limit of normal

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy (6 weeks for mitomycin)
• No prior irinotecan or other camptothecin drug
• No other concurrent chemotherapy

Endocrine therapy:

• See Disease Characteristics
• No concurrent hormonal therapy except for non-cancer-related conditions (e.g., insulin for diabetes)
• No concurrent steroids except for adrenal failure

Radiotherapy:

• See Disease Characteristics
• Prior radiotherapy for symptomatic lesions or those that might produce disability (e.g., painful bone metastases) allowed if other measurable disease present
• At least 4 weeks since prior radiotherapy
• No concurrent palliative radiotherapy

Surgery:

• See Disease Characteristics

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

karenitecin

Experimental group

Description:

Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease after 6 courses may receive 2 additional courses beyond best response. Patients are followed every 3 months for 1 year and then every 6 months thereafter.

Treatment:

Drug: karenitecin