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

NCT00387660 | Completed Phase 2 Results FDA Drug

• 4 other identifiers: UCDCC-124200210637PFIZER-Z1000752P30CA093373
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Median Survival of Patients Treated With This Regimen

  Up to 36 months

• Number of Participants With Toxicity

  Up to 36 months

Study Arms (2)

Metastatic SCLC

EXPERIMENTAL

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

Drug: carboplatin; Drug: irinotecan

Relapsed SCLC

EXPERIMENTAL

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

Drug: carboplatin; Drug: irinotecan

Interventions

carboplatin DRUG

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.

Also known as: Paraplatin, Paraplatin-AQ

Metastatic SCLC; Relapsed SCLC

irinotecan DRUG

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.

Also known as: Camptosar®, Camptothecin-11, CPT-11

Metastatic SCLC; Relapsed SCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator
• Pfizer: collaborator

Study Sites (1)

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

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

  PMID: 19204194 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

Carboplatin; Irinotecan

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds

Limitations and Caveats

Of the 80 patients, 72 were assessable.

Results Point of Contact

• Title: Analyst
• Organization: University of California, Davis

nlogihara@ucdavis.edu

916-734-8053

Study Officials

• Derick H. Lau, MD

  University of California, Davis

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 13, 2006
• Study Start: October 1, 2001
• Primary Completion: August 1, 2008
• Study Completion: January 1, 2009
• Last Updated: January 10, 2018
• Results First Posted: May 1, 2017

Record last verified: 2018-01

Locations

US (1)