Docetaxel and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

NCT00118131 | Terminated Phase 2 Results

• 4 other identifiers: CDR0000433488P30CA072720CINJ-030302CINJ-NJ1503
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 13

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, 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 docetaxel together with cisplatin works in treating patients with stage III 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)

• Overall Tumor Response Rate

  Patients experiencing complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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.", or similar definition that is accurate and appropriate.

  7 years

Secondary Outcomes (3)

• Time to Progressive Disease

  8 years

• 1-year Survival Rate

  1 year

• Median Survival Time

  10 years

Study Arms (1)

Docetaxel and Cisplatin

EXPERIMENTAL

A cycle is defined as an interval of 28 days. Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2). Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2). Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15.

Drug: cisplatin; Drug: docetaxel

Interventions

cisplatin DRUG

Docetaxel and Cisplatin

docetaxel DRUG

Docetaxel and Cisplatin

Eligibility Criteria

• Age: 18 Years - 120 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, meeting 1 of the following stage criteria: * Stage IIIB disease with malignant pericardial or malignant pleural effusions, as indicated by 1 of the following: * Positive cytology * Exudative effusion AND lactic dehydrogenase (LDH) \> 200 IU with effusion/serum LDH ratio ≥ 0.6 * Stage IV disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques OR \> 10 mm by spiral CT scan * Brain metastases allowed provided they have been irradiated AND are radiographically stable for ≥ 28 days after the completion of radiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL Hepatic * AST and ALT normal * Bilirubin normal Renal * Creatinine clearance ≥ 50 mL/min Immunologic * No known HIV positivity * No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No clinically significant active infection Other * Not pregnant or nursing * Fertile patients must use effective contraception before, during, and for 4 weeks after completion of study treatment * No other primary malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No other serious systemic disorder that would preclude study participation * No other condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Prior antibody-based therapy that targets growth factor pathways (e.g., epidermal growth factor receptor \[EGFR\]) allowed provided there is disease progression during therapy and patient has recovered * No concurrent immunotherapy * No concurrent prophylactic colony-stimulating factors * No concurrent interleukin-11 Chemotherapy * No prior cytotoxic chemotherapy * No other concurrent chemotherapy Endocrine therapy * No concurrent hormonal therapy for the malignancy Radiotherapy * See Disease Characteristics * More than 28 days since prior radiotherapy and recovered * No prior radiotherapy to ≥ 25% of the bone marrow * No prior radiotherapy to sites of measurable disease unless there is documented tumor progression after completion of radiotherapy * No concurrent radiotherapy Surgery * No concurrent surgery for the malignancy Other * More than 3 weeks since prior investigational drugs * Prior oral small molecule drug therapy that targets growth factor pathways (e.g., EGFR) allowed provided there is disease progression during therapy and patient has recovered * No other concurrent investigational or commercial agents or therapies for the malignancy

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

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Aventis Pharmaceuticals: collaborator

Study Sites (13)

Central Jersey Oncology Center, PA - East Brunswick

East Brunswick, New Jersey, 08816, United States

Location

JFK Medical Center in Edison

Edison, New Jersey, 08818, United States

Location

CentraState Medical Center

Freehold, New Jersey, 07728, United States

Location

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

Mountainside Hospital Cancer Center

Montclair, New Jersey, 07042, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07754, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08903, United States

Location

UMDNJ - University Hospital

Newark, New Jersey, 07103, United States

Location

Raritan Bay Medical Center

Perth Amboy, New Jersey, 08861, United States

Location

Somerset Medical Center

Somerville, New Jersey, 08876, United States

Location

Overlook Hospital

Summit, New Jersey, 07901, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Joseph Aisner
• Organization: Cancer Institute of New Jersey

aisnerjo@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu

732-235-8675

Study Officials

• Joseph Aisner, MD

  Rutgers Cancer Institute of New Jersey

  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: SPONSOR

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 11, 2005
• Study Start: December 1, 2003
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: August 15, 2023
• Results First Posted: November 25, 2013

Record last verified: 2023-07

Locations

US (13)