Gemcitabine and Carboplatin Followed By Docetaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00074204 | Completed Phase 3 DMC

• 4 other identifiers: LILY1503P30CA043703CASE-CWRU-LILY-1503LILLY-B9E-US-S245
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which treatment regimen is more effective for stage IIIB or stage IV non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine and carboplatin followed immediately by docetaxel with that of giving delayed docetaxel in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Survival

  Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter

Secondary Outcomes (4)

• Response rate (partial and complete response)

  Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter

• Time to progression

  treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression.

• Toxicity as measured by NCI CTC

  at baseline and at the end of each course not at day 8

• Quality of life as measured by the lung cancer symptom scale

  At baseline, at restaging, before courses 2-6 of docetaxel*, and then at 1 and 3 months after study treatment. Arm II, QOL is assessed every 3 weeks until first disease progression and then before courses 2-6 of docetaxel.

Study Arms (2)

Immediate Docetaxel

EXPERIMENTAL

Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1.

Drug: carboplatin; Drug: docetaxel; Drug: gemcitabine hydrochloride

Delayed Docetaxel

ACTIVE COMPARATOR

Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1.

Drug: carboplatin; Drug: docetaxel; Drug: gemcitabine hydrochloride

Interventions

carboplatin DRUG

Carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Delayed Docetaxel; Immediate Docetaxel

docetaxel DRUG

Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day 1. Arm II (delayed docetaxel): Patients are observed until first evidence of disease progression and then receive docetaxel IV over 1 hour on day 1. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Delayed Docetaxel; Immediate Docetaxel

gemcitabine hydrochloride DRUG

Gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Delayed Docetaxel; Immediate Docetaxel

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage IIIB with pleural effusion OR stage IV disease * Recurrent disease after primary treatment with radiotherapy or surgery allowed * Measurable disease or nonmeasurable disease * Measurable disease, defined as at least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Nonmeasurable disease, defined as all other lesions, including small lesions (longest diameter less than 20 mm by conventional techniques OR less than 10 mm by spiral CT scan) or any of the following: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Inflammatory breast disease * Lymphangitis cutis/pulmonis * Cystic lesions * Abdominal masses not confirmed and followed by imaging techniques * No symptomatic CNS metastases * Treated, stable CNS metastases allowed provided patient is not receiving radiotherapy or corticosteroids PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 3.0 times upper limit of normal (ULN) (less than 5.0 times ULN for patients with documented benign disease) * Alkaline phosphatase less than 3.0 times ULN (for patients with documented benign disease) Renal * Creatinine no greater than 1.5 mg/dL Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after study participation * No active and ongoing infection * No concurrent serious systemic disorder that would preclude study participation * No other primary malignancy within the past 5 years except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or T1 vocal cord cancer in remission * Other prior cancers unlikely to affect survival for the next 3 years (e.g., low-grade early stage prostate cancer) are allowed PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * No prior chemotherapy for NSCLC, including neoadjuvant and adjuvant therapy * No other concurrent chemotherapy Endocrine therapy * See Disease Characteristics * No concurrent antitumor hormonal therapy (excluding contraceptives and replacement steroids) Radiotherapy * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered * Prior radiotherapy to less than 25% of bone marrow allowed provided the irradiated area is not the only site of measurable disease * No concurrent radiotherapy Surgery * See Disease Characteristics Other * At least 3 weeks since prior therapy for cancer * More than 4 weeks since prior investigational agents * No other concurrent experimental medications * No other concurrent therapy for cancer

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Docetaxel; Gemcitabine

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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Nathan Levitan, MD

  Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2003
• First Posted: December 11, 2003
• Study Start: October 1, 2003
• Primary Completion: August 1, 2005
• Study Completion: April 1, 2008
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

US (1)