Docetaxel and Cisplatin With or Without Dimesna 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):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00077311
First received: February 10, 2004
Last updated: September 28, 2013
Last verified: September 2013
  Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by chemotherapy.

PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.


Condition Intervention Phase
Anemia
Drug/Agent Toxicity by Tissue/Organ
Lung Cancer
Neutropenia
Biological: darbepoetin alfa
Biological: pegfilgrastim
Drug: cisplatin
Drug: docetaxel
Drug: BNP7787
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: A Phase II Randomized Study Of Dose-Dense Docetaxel And Cisplatin Every Two Weeks With Pegfilgrastim And Darbepoetin Alfa With And Without The Chemoprotector BNP7787 In Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity


Secondary Outcome Measures:
  • Response [ Time Frame: during tx,q 3 mon for 1 yr, then q 6 mon for 2 yrs ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: q 6 mon for 2 yrs after registration, then annually ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: August 2004
Study Completion Date: April 2009
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy without BNP7787
Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
Biological: darbepoetin alfa
200 mcg sub Q on day 1 of each cycle if HgB < or = 11 g/dL
Biological: pegfilgrastim
6 mg sub Q day 2 of each cycle
Drug: cisplatin
75 mg/sq m IV over 1 hr Day 1 of each cycle
Drug: docetaxel
75 mg/sq m IV over 1 hr Day 1 of each cycle
Experimental: Chemotherapy + BNP7787
Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
Biological: darbepoetin alfa
200 mcg sub Q on day 1 of each cycle if HgB < or = 11 g/dL
Biological: pegfilgrastim
6 mg sub Q day 2 of each cycle
Drug: cisplatin
75 mg/sq m IV over 1 hr Day 1 of each cycle
Drug: docetaxel
75 mg/sq m IV over 1 hr Day 1 of each cycle
Drug: BNP7787
40 g IV over 30 min Day 1 of each cycle

Detailed Description:

OBJECTIVES:

Primary

  • Compare the incidence and severity of peripheral neuropathy in patients with stage IIIB or IV non-small cell lung cancer treated with docetaxel and cisplatin with or without dimesna.
  • Compare the feasibility of these regimens, in terms of febrile neutropenia and treatment delays, in these patients.
  • Compare the objective response rate in patients treated with these regimens.

Secondary

  • Compare the survival and failure-free survival of patients treated with these regimens.
  • Compare the toxicity profile of these regimens in these patients.
  • Compare the incidence and severity of cisplatin-induced nephrotoxicity in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I*: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 and pegfilgrastim subcutaneously (SC) on day 2.
  • Arm II*: Patients receive docetaxel, cisplatin, and pegfilgrastim as in arm I and dimesna IV over 30 minutes on day 1.

NOTE: *In both arms, darbepoetin alfa is administered SC on day 1 of each course for hemoglobin ≤ 11 g/dL.

In both arms, treatment repeats every 2 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 152 patients (76 per treatment arm) will be accrued for this study within 18-20 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed* non-small cell lung cancer of 1 of the following subtypes:

    • Squamous carcinoma
    • Basaloid carcinoma
    • Adenocarcinoma
    • Bronchoalveolar carcinoma
    • Adenosquamous carcinoma
    • Large cell carcinoma
    • Large cell neuroendocrine carcinoma
    • Giant cell carcinoma
    • Sarcomatoid carcinoma
    • Non-small cell carcinoma not otherwise specified NOTE: *Histologic or cytologic confirmation of recurrence is required for patients who have undergone prior complete resection
  • Stage IIIB disease due to malignant pleural effusion OR stage IV disease
  • Measurable disease

    • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • The following are considered nonmeasurable disease:

      • Bone lesions
      • Brain metastases or leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Abdominal masses not confirmed and followed by imaging techniques
      • Cystic lesions
      • Tumor lesions situated in a previously irradiated area
  • Brain metastases are allowed provided patient is neurologically stable and off steroids

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 mg/dL
  • AST ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ ULN

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No grade 2 or greater neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No other concurrent growth factors

Chemotherapy

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent hormonal therapy except steroids administered for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic

Radiotherapy

  • See Disease Characteristics
  • Prior radiotherapy allowed for brain metastases only
  • No concurrent palliative radiotherapy

Surgery

  • See Disease Characteristics
  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: NCT00077311

  Show 64 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Antonius A. Miller, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Publications:
Green MR, Miller AA, Wang XF, et al.: Phase II randomized study of dose-dense docetaxel (Doc) and cisplatin (Cis) every two weeks with pegfilgrastim (Pfil) and darbepoetin alfa (Darb) with and without the chemoprotector BNP7787 in patients with advanced non-small cell lung cancer (NSCLC): CAL. [Abstract] J Clin Oncol 25 (Suppl 18): A-7617, 413s, 2007.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00077311     History of Changes
Other Study ID Numbers: CDR0000350089, U10CA031946, CALGB-30303
Study First Received: February 10, 2004
Last Updated: September 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
drug/agent toxicity by tissue/organ
anemia
neutropenia
stage IV non-small cell lung cancer
stage IIIB non-small cell lung cancer
recurrent non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
adenosquamous cell lung cancer

Additional relevant MeSH terms:
Anemia
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neutropenia
Hematologic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Docetaxel
Cisplatin
Darbepoetin alfa
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on August 27, 2014