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Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003587
  Purpose

RATIONALE: Drugs used in chemotherapy 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.

PURPOSE: Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: cisplatin
Drug: docetaxel
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Drug: vinorelbine ditartrate
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: Randomized Phase II Trial of Carboplatin/Gemcitabine Followed By Paclitaxel or Cisplatin/Vinorelbine Followed by Docetaxel in Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 160
Study Start Date: October 1998
Detailed Description:

OBJECTIVES: I. Assess the survival and failure free survival of patients with advanced primary non-small cell lung cancer treated with carboplatin and gemcitabine followed by paclitaxel OR cisplatin and vinorelbine followed by docetaxel. II. Evaluate the response (confirmed plus unconfirmed) and toxicities associated with these two regimens in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8.

Treatment repeats every 21 days for 3 courses. Following the 3 courses of carboplatin and gemcitabine, patients receive paclitaxel IV over 3 hours on day 1 every 21 days for 3 courses. Arm II: Patients receive cisplatin IV over 30-60 minutes on day 1 followed by vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Following the 3 courses of cisplatin and vinorelbine, patients receive docetaxel IV over 1 hour on day 1 every 21 days for 3 courses. Patients receive no further treatment until evidence of disease progression. Patients are followed every 2 months for the first year, every 6 months for years 2 and 3, and annually thereafter.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed stage IIIB or IV advanced primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous cell carcinoma, or unspecified) or recurrent non-small cell lung cancer after previous surgery and/or radiotherapy Stage IIIB: T4 lesion due to malignant pleural effusion, OR multiple lesions in a single lobe containing a T3 or T4 primary, OR lesions in multiple lobes of the ipsilateral lung for which one such lesion is T3 or T4 Any N M0 Stage IV: Any T, Any N, M1 Measurable or evaluable disease Measurable or evaluable disease must be outside of the prior radiotherapy port or prior surgical resection area No brain metastases No bronchoalveolar carcinoma or stage IIIB tumor involving the superior sulcus (pancoast tumors)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no greater than 2 times upper limit of normal AND Creatinine clearance at least 50 mL/min Other: No prior malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently in complete remission Not pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for non-small cell lung cancer No concurrent biologic therapy to measurable or evaluable lesions Chemotherapy: No prior systemic chemotherapy for non-small cell lung cancer Endocrine therapy: No concurrent hormonal therapy to measurable or evaluable lesions Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No concurrent radiotherapy to measurable lesions Palliative radiation to small field nonmeasurable sites of disease (painful bony metastases) allowed Surgery: At least 3 weeks since surgery (thoracic or other major surgeries) and recovered

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003587

  Show 84 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Martin J. Edelman, MD Veterans Affairs Medical Center - Baltimore
  More Information

Additional Information:
Publications:
Edelman MJ, Clark JI, Chansky K, Albain K, Bhoopalam N, Weiss GR, Giguere JK, Kelly K, Crowley J, Gandara DR. Randomized phase II trial of sequential chemotherapy in advanced non-small cell lung cancer (SWOG 9806): carboplatin/gemcitabine followed by paclitaxel or cisplatin/vinorelbine followed by docetaxel. Clin Cancer Res. 2004 Aug 1;10(15):5022-6.
Edelman MJ, Clark JI, Chansky K, et al.: Randomized phase II trial of sequential chemotherpy in advanced non-small cell lung cancer (SWOG 9806): carboplatin/gemcitabine (CARB/G) followed by paclitaxel (P) or cisplatin/vinorelbine (C/V) followed by docetaxel (D). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1254, 314, 2001.
Lara PN Jr, Redman MW, Kelly K, Edelman MJ, Williamson SK, Crowley JJ, Gandara DR; Southwest Oncology Group. Disease control rate at 8 weeks predicts clinical benefit in advanced non-small-cell lung cancer: results from Southwest Oncology Group randomized trials. J Clin Oncol. 2008 Jan 20;26(3):463-7.
Lara PN Jr, Redman MW, Kelly K, et al.: Alternative measures predicting clinical benefit in advanced non-small cell lung cancer (NSCLC) from Southwest Oncology Group (SWOG) randomized trials: implications for clinical trial design. [Abstract] J Clin Oncol 24 (Suppl 18): A-7006, 365s, 2006.

Study ID Numbers: CDR0000066656, SWOG-9806
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003587     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung

Study placed in the following topic categories:
Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Immunologic Factors
Vinblastine
Docetaxel
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Gemcitabine
Antimitotic Agents
Carboplatin
Antiviral Agents
Immunosuppressive Agents
Recurrence
Carcinoma
Vinorelbine
Radiation-Sensitizing Agents
Paclitaxel
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Adenocarcinoma of Lung
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Vinblastine
Docetaxel
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses
Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Vinorelbine
Radiation-Sensitizing Agents
Paclitaxel

ClinicalTrials.gov processed this record on September 01, 2009