Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma

Cystadenocarcinoma, Mucinous

Fallopian Tube Neoplasms

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

Fallopian Tube Diseases

Adenocarcinoma

Neoplasms, Cystic, Mucinous, and Serous

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Adenocarcinoma of the Appendix

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Capecitabine

Paclitaxel

Carboplatin

Bevacizumab

Albumin-Bound Paclitaxel

Oxaliplatin

Immunoglobulins

Immunoglobulin G

Endothelial Growth Factors

Mitogens

Immunoglobulins, Intravenous

Antineoplastic Agents, Immunological

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

Immunologic Factors

Antimetabolites

Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.

Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.

Laboratory Biomarker Analysis

Quality-of-Life Assessment

David M Gershenson

This randomized phase III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.

PRIMARY OBJECTIVES:

I. To determine if capecitabine and oxaliplatin reduces the death rate compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube.

II. To determine if bevacizumab reduces the death rate compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube.

SECONDARY OBJECTIVES:

I. To determine if capecitabine and oxaliplatin increases the duration of progression-free survival (PFS) compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube.

II. To determine if bevacizumab increases the duration of PFS compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube.

III. To compare the response rates for capecitabine and oxaliplatin versus carboplatin and paclitaxel in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery.

IV. To compare the response rates for bevacizumab versus no bevacizumab in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery.

V. To determine the nature and degree of toxicity of capecitabine and oxaliplatin compared with that of carboplatin and paclitaxel in this cohort of patients.

VI. To determine the nature and degree of toxicity of bevacizumab in this cohort of patients.

VII. To compare capecitabine and oxaliplatin versus carboplatin and paclitaxel with respect to changes in patient reported neurotoxicity.

VIII. To determine the impact on quality of life (QOL, as measured by the Functional Assessment of Cancer Therapy-Ovarian \[FACT-O\] Trial Outcome Index \[TOI\]) following treatment with the above regimens.

TERTIARY OBJECTIVES:

I. To collect fixed and/or frozen tissue and whole blood for future research studies.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive carboplatin intravenously (IV) over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.

ARM IV: Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.

After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.

Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer

A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients With Mucinous Epithelial Ovarian or Fallopian Tube Cancer (MEOC)

Will be tabulated. Interactions between the mutational status of the KRAS oncogene and treatment will be examined.

Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact.

Grade 1 or higher non-serious adverse events were graded by CTC AE v 4.

Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),.\>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR

Patient reported neurotoxicity symptoms as 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 4 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). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.

Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. The FACT-O TOI score ranges 0-100 with a large score suggests better QOL

NRG Oncology

National Cancer Institute (NCI)

Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Arm I (Carboplatin and Paclitaxel)

Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given PO

Laboratory Biomarker Analysis: Correlative studies

Oxaliplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Arm II (Oxaliplatin and Capecitabine)

Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.

Bevacizumab: Given IV

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Arm III (Carboplatin, Paclitaxel, Bevacizumab)

Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.

Bevacizumab: Given IV

Capecitabine: Given PO

Laboratory Biomarker Analysis: Correlative studies

Oxaliplatin: Given IV

Quality-of-Life Assessment: Ancillary studies

Arm IV (Oxaliplatin, Capecitabine, Bevacizumab)

Total

Age, Customized

Sex: Female, Male

The majority of patients were deemed not to have primary mucinous ovarian cancer post hoc. The trial accrued slowly and was stopped early.

Linda Gedeon on behalf of William Brady, PhD

Overall Survival

Abnormal lab values

Allergic reaction

Allergic rhinitis

Alopecia

Anemia

Bleeding

Cold-like symptoms

Constipation

Diarrhea

dyspnea

Edema Limbs

Fatigue

Fever

Hand/Foot Syndrome

Headache

Hypertension

Hypomagnesemia

Infection

Laryngeal Spasm

Low Lymphocytes

Low Mood

Low Neutrophils

Low platelets

Low white Blood Cells

Mucositis

Nausea/Vomiting

Oral Problems

Other

Pain

Peripheral/Sensory Neuropathy

Pneumothorax

Raised CA19-9

Raised Blood Counts

Rash

Stomatitis

Taste Alteration

Urinary Problems

Vaginal Bleeding

Weight Gain

Weight Loss

Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0

Progression-free Survival

All randomized patients with measurable disease

Objective Tumor Response

Baseline (pre-treatment)

Pre-cycle 4

Post cycle 6

Six months post chemo

End of bevacizumab (BEV)

Six months after BEV

2 years after BEV

3 years after BEV

4 years after BEV

5 years after BEV

Patients who provided a valid FACT/GOG-Ntx subscale assessment. Data were not collected at certain time points for certain arms.

Patient Reported Neurotoxicity

Pre-Cycle 4

Post-Cycle 6

Six Months Post-Chemo

End of Bevacizumab (BEV)

Six Months after BEV

2 Years after BEV

3 Years after BEV

4 Years after BEV

5 Years after BEV

All Randomized Patients with at least one post-baseline QOL assessment reported were averaged. Data were not collected at certain time points for certain arms.

Patient Reported Quality of Life

Numbers and Percentages of Patients With Mutations in the Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Oncogene

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer	NCT01081262	Borderline Ovar... Ovarian Mucinou... Recurrent Fallo... Recurrent Ovari... Stage IA Fallop... Stage IA Ovaria... Stage IB Fallop... Stage IB Ovaria... Stage IC Fallop... Stage IC Ovaria... Stage IIA Fallo... Stage IIA Ovari... Stage IIB Fallo... Stage IIB Ovari... Stage IIC Fallo... Stage IIC Ovari... Stage IIIA Fall... Stage IIIA Ovar... Stage IIIB Fall... Stage IIIB Ovar... Stage IIIC Fall... Stage IIIC Ovar... Stage IV Fallop... Stage IV Ovaria...	Bevacizumab Capecitabine Carboplatin Laboratory Biom... Oxaliplatin Paclitaxel Quality-of-Life...	18 Years -	National Cancer Institute (NCI)
Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer	NCT01081262	Borderline Ovar... Ovarian Mucinou... Recurrent Fallo... Recurrent Ovari... Stage IA Fallop... Stage IA Ovaria... Stage IB Fallop... Stage IB Ovaria... Stage IC Fallop... Stage IC Ovaria... Stage IIA Fallo... Stage IIA Ovari... Stage IIB Fallo... Stage IIB Ovari... Stage IIC Fallo... Stage IIC Ovari... Stage IIIA Fall... Stage IIIA Ovar... Stage IIIB Fall... Stage IIIB Ovar... Stage IIIC Fall... Stage IIIC Ovar... Stage IV Fallop... Stage IV Ovaria...	Bevacizumab Capecitabine Carboplatin Laboratory Biom... Oxaliplatin Paclitaxel Quality-of-Life...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for borderline ovarian mucinous tumor