Irinotecan and Carboplatin in Treating Patients With Metastatic or Recurrent Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Phase II Study of Irinotecan and Carboplatin in Metastatic or Relapsed Small-Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387660
• Other study ID #: UCDCC-124
• Secondary ID: 200210637PFIZER-
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2006
• Last updated: January 5, 2018
• Start date: October 2001
• Est. completion date: January 2009

Study information

• Verified date: January 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with metastatic or recurrent small cell lung cancer.

Description:

OBJECTIVES:

• Determine the response rates in patients with metastatic or recurrent small cell lung cancer treated with irinotecan hydrochloride and carboplatin.

• Determine the median survival of patients treated with this regimen.

• Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and disease stage (metastatic vs relapsed).

Patients receive irinotecan hydrochloride IV over 90 minutes and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Other known NCT identifiers

• NCT00462800

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed small cell lung cancer, meeting 1 of the following criteria:

• Previously untreated metastatic or extensive disease

• Malignant pleural effusion or multifocal lung disease is considered metastatic or extensive disease

• Prior radiotherapy allowed

• Recurrent disease

• Limited, metastatic, or extensive disease

• Relapsed after prior chemotherapy, excluding irinotecan hydrochloride

• At least 90 days since prior chemotherapy

• Measurable disease, defined as = 1 unidimensionally measurable lesion = 1 cm by physical examination or radiographic techniques

• Known brain metastases allowed

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy = 3 months

• White Blood Cells > 3,000/mm³

• Absolute neutrophil count = 1,500/mm³

• Platelet count = 100,000/mm³

• Hemoglobin = 9.0 g/dL

• Bilirubin = 1.5 mg/dL

• SGOT = 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

• No medical disease that, in the opinion of the investigator, would preclude study treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 10 days since prior radiotherapy (including brain)

• No prior irinotecan hydrochloride

• At least 2 weeks since prior and no concurrent anticonvulsants

• No concurrent radiotherapy

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• carboplatin
Patients receive carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
• irinotecan
Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Locations

Country	Name	City	State
United States	University of California Davis Cancer Center	Sacramento	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	National Cancer Institute (NCI), Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chen G, Huynh M, Fehrenbacher L, West H, Lara PN Jr, Yavorkovsky LL, Russin M, Goldstein D, Gandara D, Lau D. Phase II trial of irinotecan and carboplatin for extensive or relapsed small-cell lung cancer. J Clin Oncol. 2009 Mar 20;27(9):1401-4. doi: 10.12 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by radiographic techniques. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	Up to 36 months
Secondary	Median Survival of Patients Treated With This Regimen	The length of time from the start of treatment that half of the patients in a group of patients diagnosed with the disease are still alive.	Up to 36 months
Secondary	Number of Participants With Toxicity	All adverse events were graded according to the National Cancer InstituteCommon Toxicity Criteria, version 2.0. All 80 patients were assessable for toxicity at least for the first cycle.	Up to 36 months