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

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

carboplatin

irinotecan

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer, limited stage small cell lung cancer, recurrent small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of California Davis Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Metastatic SCLC

Relapsed SCLC

Arm Description

Irinotecan 200 mg/m2, every 21 days (intravenous) + Carboplatin AUC = 5 mg/ml x min (intravenous), every 21 days for 6 cycles

Irinotecan 150 mg/m2 (intravenous), every 21 days + Carboplatin AUC = 5 mg/ml x min (intravenous, every 21 days for 6 cycles

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT00387660

First Posted

October 12, 2006

Last Updated

January 5, 2018

Sponsor

University of California, Davis

Collaborators

National Cancer Institute (NCI), Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00387660

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

October 2001 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

Collaborators

National Cancer Institute (NCI), Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

extensive stage small cell lung cancer, limited stage small cell lung cancer, recurrent small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metastatic SCLC

Arm Type

Experimental

Arm Description

Irinotecan 200 mg/m2, every 21 days (intravenous) + Carboplatin AUC = 5 mg/ml x min (intravenous), every 21 days for 6 cycles

Arm Title

Relapsed SCLC

Arm Type

Experimental

Arm Description

Irinotecan 150 mg/m2 (intravenous), every 21 days + Carboplatin AUC = 5 mg/ml x min (intravenous, every 21 days for 6 cycles

Intervention Type

Drug

Intervention Name(s)

carboplatin

Other Intervention Name(s)

Paraplatin, Paraplatin-AQ

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

irinotecan

Other Intervention Name(s)

Camptosar®, Camptothecin-11, CPT-11

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall Response Rate

Description

Time Frame

Up to 36 months

Secondary Outcome Measure Information:

Title

Median Survival of Patients Treated With This Regimen

Description

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.

Time Frame

Up to 36 months

Title

Number of Participants With Toxicity

Description

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.

Time Frame

Up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Derick H. Lau, MD

Organizational Affiliation

University of California, Davis

Official's Role

Study Chair

Facility Information:

Facility Name

University of California Davis Cancer Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19204194

Citation

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: 10.1200/JCO.2008.20.2127. Epub 2009 Feb 9.

Results Reference

result

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

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