Irinotecan and Carboplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

NCT00469898 | Completed Phase 2 Results DMC

• 2 other identifiers: VICC THO 0321VU-VICC-THO-0321
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 8

Brief Summary

RATIONALE: The general results of combining irinotecan and platin-based chemotherapies have been very encouraging. As the toxicity profile associated with carboplatin is preferable over cisplatin it is our expectation that patients and physicians would prefer to use this combination if it is equally or more efficacious. To date there has been no agreement regarding the optimal combination of these agents. Based on the trials described in the protocol and our experience with carboplatin/irinotecan in the treatment of non-small cell lung cancer the present trial will utilize a 21-day cycle of irinotecan 50 mg/m2 given on days 1 and 8 and carboplatin AUC 5 (based on the Calvert formula) on day 1. PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works as first-line therapy in treating patients with extensive-stage small cell lung cancer.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Patient Response

  Patient response to treatment: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD

  1.66 months (average duration, on treatment date to best response date)

Secondary Outcomes (3)

• Number of Patients With Adverse Events

  date off treatment or progression of disease, up to 18 weeks

• Time to Progression

  9.9 months (on study date to progression)

• Overall Survival

  On study date to death

Study Arms (1)

Therapeutic Intervention

EXPERIMENTAL

Lung cancer patients will be treated for four 3-week cycles (12 weeks) in the absence of progressive disease, unacceptable toxicity, or withdrawal of patient consent. Up to two additional cycles may be administered at the discretion of the treating physician. If at treatment withdrawal the disease has responded or is stable, the patient will continue to be followed for efficacy (i.e. until progressive disease)at 8 week intervals. Following the diagnosis of progressive disease, patients will be followed every two months for survival.

Drug: Carboplatin; Drug: irinotecan hydrochloride

Interventions

Carboplatin DRUG

Carboplatin dosage calculation to be given on day 1, every 21 days: Carboplatin (mg) = (AUC of 5) x (GFR + 25) \*up to 6 cycles at physician's discretion

Also known as: Paraplatin

Therapeutic Intervention

irinotecan hydrochloride DRUG

50 mg/m2 IV on days 1 and 8 every 21 days Should be infused IV over 30- 90 minutes.

Also known as: Irinotecan, Camptosar, CPT-11

Therapeutic Intervention

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed small cell lung cancer (SCLC)
• Extensive stage small cell lung cancer
• Must have ≥ 1 unidimensionally measurable lesion (longest diameter to be recorded) ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Lesion cannot be from a previously irradiated area
• Lesions that are considered nonmeasurable include the following:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Lymphangitis cutis/pulmonis
• Abdominal masses not confirmed and followed by imaging techniques
• Cystic lesions
• Tumor lesions in a previously irradiated area
• No brain metastasis or carcinomatous meningitis unless stable and asymptomatic
• PATIENT CHARACTERISTICS

You may not qualify if:

• CNS metastasis excluded unless: stable and asymptomatic
• Coexisting medical condition that would preclude study compliance
• Patients with Gilbert's disease
• Uncontrolled diabetes mellitus, defined as random blood sugar ≥ 300 mg/dl or \> 16.6 mmol/L
• Patients who do not discontinue phenytoin, phenobarbitol, carbamazipine, or other enzyme-inducing anticonvulsant drugs at least 7 days prior to first treatment dose on study. Gabapentin is permitted
• Patients who do not discontinue St. John's Wort prior to first treatment dose on study.
• Patients who are pregnant or breast feeding
• Concomitant second active malignancy except for any in situ cancer or adequately treated basal cell or squamous cell skin cancer or any cancer from which the patients has been disease-free for at least 2 years
• No administration of any prior systemic anticancer therapy for extensive stage SCLC such as: chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents. Concurrent use of other anticancer therapy including inhibitors of vascular endothelial or epidermal growth factor pathways is prohibited. Prior radiation is allowed
• Symptomatic brain metastasis or carcinomatous meningitis
• PRIOR CONCURRENT THERAPY:

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

Owensboro Medical Health System

Owensboro, Kentucky, 42303, United States

Location

Memorial Health Care System

Chattanooga, Tennessee, 37404, United States

Location

West Tennessee Cancer Center at Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

Tennessee Cancer Specialists

Knoxville, Tennessee, 37901, United States

Location

St. Thomas Health Services

Nashville, Tennessee, 37205, United States

Location

MBCCOP - Meharry Medical College - Nashville

Nashville, Tennessee, 37208, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, V52 4, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Carboplatin; Irinotecan

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Leora Horn, M.D.
• Organization: Vanderbilt-Ingram Cancer Center

leora.horn@vanderbilt.edu

615-322-4967

Study Officials

• Leora Horn, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: December 1, 2003
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2010
• Last Updated: July 27, 2012
• Results First Posted: March 23, 2011

Record last verified: 2012-07

Locations

US (7); CA (1)