S9806: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00003587
First received: November 1, 1999
Last updated: October 5, 2012
Last verified: October 2012
  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
Drug: paclitaxel
Drug: vinorelbine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Southwest Oncology Group:

Enrollment: 204
Study Start Date: October 1998
Study Completion Date: January 2007
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: carboplatin/gemcitabine/paclitaxel
IV carboplatin AUC=5.5 day 1 every 21 days X 3 IV gemcitabine 1,000 mg/m^2/day, days 1 and 8 every 21 days X3 IV paclitaxel 225 mg/m^2/day, day 1 every 21 days X 3
Drug: carboplatin
AUC=5.5 day 1 every 21 days X 3
Other Name: carbo
Drug: gemcitabine
IV gemcitabine 1,000 mg/m^2/day, days 1 and 8 every 21 days X3
Other Name: gemzar
Drug: paclitaxel
IV paclitaxel 225 mg/m^2/day, day 1 every 21 days X 3
Other Name: taxol
Experimental: cisplatin/vinorelbine/docetaxel
IV cisplatin 100 mg/m^2 day 1 every 21 days X 3 IV vinorelbine 25 mg/m^2/day, days 1 and 8 every 21 days X 3 IV docetaxel 75 mg/m^2 day 1 every 21 days X 3
Drug: cisplatin
IV cisplatin 100 mg/m^2 day 1 every 21 days X 3
Other Name: platinol
Drug: docetaxel
IV docetaxel 75 mg/m^2 day 1 every 21 days X 3
Other Name: taxotere
Drug: vinorelbine
IV vinorelbine 25 mg/m^2/day, days 1 and 8 every 21 days X 3
Other Name: navelbine

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 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, 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.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00003587     History of Changes
Other Study ID Numbers: CDR0000066656, S9806, U10CA032102
Study First Received: November 1, 1999
Last Updated: October 5, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
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

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

ClinicalTrials.gov processed this record on July 31, 2014