High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Cancer
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give
      higher doses of chemotherapy drugs and kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral
      stem cell transplantation in treating patients who have advanced cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the feasibility of administering 2 courses of high dose chemotherapy consisting
           of etoposide, cisplatin, and cyclophosphamide followed by ifosfamide, carboplatin, and
           paclitaxel (IC-T), each administered with filgrastim (G-CSF) and autologous stem cell
           support, to patients with advanced carcinomas.

        -  Describe the toxicity of these high dose chemotherapy regimens.

        -  Define the maximum tolerated dose of paclitaxel deliverable in this high dose regimen.

        -  Describe the pharmacokinetics of escalating doses of paclitaxel given as a 24-hour
           continuous infusion.

        -  Determine the disposition of carboplatin administered in the IC-T regimen.

      OUTLINE: At least 4 weeks prior to chemotherapy, patients undergo stem cell collection
      following filgrastim (G-CSF) mobilization. Sufficient stem cells to support 2 courses of
      chemotherapy are required. Autologous bone marrow is collected as an adjuvant if stem cell
      harvest is inadequate.

      Patients then receive high dose cisplatin, etoposide, and cyclophosphamide over 10 days,
      followed the next day by infusion of one fourth of the allotted stem cells, with the
      remaining allotment infused 2 days later. G-CSF is given for granulocyte support.

      Beginning no sooner than 14 weeks from the start of the first course of chemotherapy, stable
      and responding patients receive high dose paclitaxel, carboplatin, and ifosfamide over 5
      days, followed 2 days later with one-fourth of the allotted stem cells, with the remaining
      allotment infused the following day. G-CSF is given for granulocyte support. Groups of 3-6
      patients are treated with escalating doses of paclitaxel until the maximum tolerated dose for
      this regimen is determined.

      Patients are followed monthly for 1 year, every 3 months for 1 year, then as needed at the
      physician's discretion for at least 5 years.

      PROJECTED ACCRUAL: Three to six patients will be entered at each dose of paclitaxel studied.
    

Intervention name(s): filgrastim; carboplatin; cisplatin; cyclophosphamide; etoposide; ifosfamide; mesna; paclitaxel; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Paclitaxel; Etoposide; Cyclophosphamide; Carboplatin; Ifosfamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage II breast cancer; stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IV gastric cancer; recurrent gastric cancer; localized osteosarcoma; metastatic osteosarcoma; stage IIIB breast cancer; recurrent pancreatic cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; stage IV anal cancer; recurrent anal cancer; stage IV esophageal cancer; recurrent esophageal cancer; stage III adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer; recurrent Wilms tumor and other childhood kidney tumors; advanced adult primary liver cancer; recurrent adult primary liver cancer; recurrent osteosarcoma; recurrent gallbladder cancer; recurrent extrahepatic bile duct cancer; recurrent small intestine cancer; stage II melanoma; stage III melanoma; stage IV melanoma; recurrent melanoma; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor; stage IV adult soft tissue sarcoma; stage IV pancreatic cancer