Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Sarcoma

Carcinosarcoma

Mixed Tumor, Mullerian

Mixed Tumor, Mesodermal

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Adenoma, Pleomorphic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Connective and Soft Tissue

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Fallopian Tube Cancer

Malignant Mixed Mullerian Tumor

Ovarian Carcinosarcoma

Uterine Sarcoma

Uterine Carcinosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Paclitaxel

Cyclophosphamide

Carboplatin

Albumin-Bound Paclitaxel

Ifosfamide

Isophosphamide mustard

Mechlorethamine

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1.

Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I.

Quality-of-Life Assessment

Matthew A Powell

This randomized phase III trial studies paclitaxel and carboplatin see how well they work compared with paclitaxel and ifosfamide in treating patients with fallopian tube, or peritoneal cavity cancer that is newly diagnosed, persistent, or has come back (recurrent). Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether paclitaxel is more effective when given with carboplatin or ifosfamide in treating patients with uterine, ovarian, fallopian tube, or peritoneal cavity cancer.

PRIMARY OBJECTIVES:

I. To determine if treatment with combination paclitaxel and carboplatin (TC) chemotherapy does not result in an inferior death rate when compared to ifosfamide, mesna, and paclitaxel chemotherapy.

SECONDARY OBJECTIVES:

I. To determine if treatment with combination paclitaxel and carboplatin (TC) chemotherapy does not result in an inferior progression-free survival when compared to ifosfamide, mesna, and paclitaxel chemotherapy.

II. To determine if acute toxicity, specifically physician-assessed neurotoxicity and infection, associated with combination paclitaxel and carboplatin chemotherapy is reduced compared to that of ifosfamide, mesna, and paclitaxel chemotherapy.

III. To determine if treatment with combination paclitaxel and carboplatin chemotherapy is associated with superior patient-reported quality of life and neurotoxicity scores compared to that of ifosfamide, mesna, and paclitaxel chemotherapy.

TERTIARY OBJECTIVES:

I. To bank formalin-fixed, paraffin-embedded (FFPE) tumor tissue and deoxyribonucleic acid (DNA) extracted from whole blood for future research.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours followed by carboplatin IV over 30-60 minutes on day 1.

ARM II: Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I.

In both arms, treatment repeats every 21 days for 6-10 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer

A Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naive Patients With Newly Diagnosed Stage I-IV, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus, Fallopian Tube, Peritoneum or Ovary

Measured in months from randomization to last contact or death. Primary analysis was restricted to the eligible uterine carcinosarcoma cohort.

Measured in months from randomization to last contact or the earlier of the date of progression or death.

Maximum grade experienced among all treated and eligible patients. The grades are described by severity. Grade 1 is the lowest (most mild) and Grade 5 being death (most severe). Adverse events were analyzed across cohorts since disease site was considered independent of AEs.

Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. The FACT-En TOI score ranges 0-120 with a large score suggesting better QOL. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.

Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms. Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.

Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms.Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.

National Cancer Institute (NCI)

GOG Foundation

Eligible and treated participants were affected if they experienced grade 1-5 adverse event. Adverse events were analyzed across cohorts since disease site was considered independent of AEs.

Paclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles

Regimen I - Uterine and Non-uterine Carcinosarcoma

Ifosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-6

Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects

Paclitaxel 175 mg/m2 IV over 3 hours Day 1. Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles

Regimen I - Uterine Carcinsarcoma Subjects

Regimen II - Uterine Carcinsarcoma Subjects

Regimen III - Non-uterine Carcinsarcoma Subjects

Regimen IV - Non-uterine Carcinsarcoma Subjects

Total

20-29 years

30-39 years

40-49 years

50-59 years

60-69 years

70-89 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Linda Gedeon on behalf of Virginia Filiaci, PhD.

Regimen I- Uterine Carcinsarcoma Subjects

Overall Survival

Duration of Progression-free Survival

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Regimen I - Uterine and Non-Uterine Subjects

Regimen II - All Uterine and Non-Uterine Subjects

Treated and Eligible subjects. Adverse events were analyzed across cohorts since disease site was considered independent of AEs.

Incidence of Adverse Events as Assessed by CTCAE Version 3.0

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1.

Carboplatin: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I.

Ifosfamide: Given IV

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Spots Global Cancer Trial Database for stage iiib uterine sarcoma ajcc v7