## Protocol Section
### Identification Module
**NCT ID:** NCT00158379

**Brief Title:** Taxol Carboplatin and Erythropoetin

**Official Title:** Carboplatin With Following Taxol® Therapy Under Additional Application of Epoetin Alfa (ERYPO ®) With Female Patients With Advanced Ovarian Cancer FIGO IA/G3 - IV

#### Organization Study ID Info
**ID:** 3002000
#### Organization
**Class:** OTHER
**Full Name:** North Eastern German Society of Gynaecological Oncology
### Status Module
#### Completion Date
**Date:** 2008-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-02-06

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-12-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-04

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-11-25

**Type:** ESTIMATED

**Results First Submit Date:** 2016-10-04

**Results First Submit QC Date:** 2016-10-04

#### Start Date
**Date:** 2003-07

**Status Verified Date:** 2016-12

#### Study First Post Date
**Date:** 2005-09-12
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-09
**Study First Submit QC Date:** 2005-09-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** North Eastern German Society of Gynaecological Oncology

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Time to progression (physical examination and radiologic imaging

### Conditions Module

**Conditions:**

- Ovarian Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 105

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Paclitaxel

**Label:** Paclitaxel

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Paclitaxel

**Description:** 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®

**Name:** Paclitaxel

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Time to progression

**Measure:** Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%

**Time Frame:** every 3 months for up to 3 years

#### Secondary Outcomes

**Description:** defined as hematological and non-hematological adverse events of grade \>= grade 1

**Measure:** Toxicity

**Time Frame:** after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* patients with primary ovarian cancer
* ECOG- 0-2
* Age \>= 18
* no chemotherapy, radiation or immunotherapy in medical history for ovarian cancer
* adequate bone marrow, liver and kidney reserve: leukocytes ≥ 2.0 x 109/l, platelets ≥ 100 x 109/l, bilirubin \<= 2,0 mg%, creatinine \<= 1,5 mg% or creatinine clearance ≥ 60 ml/ min, hemoglobin ≥ 9 g/ dl SGOT, SGPT an AP within 3 fold of the reference laboratory's normal range
* written informed consent

Exclusion Criteria:

* before-existing heart illness, Cardiac infarct within last 6 months
* Radiotherapy within 4 weeks for study entry
* Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intrauterine devices, surgical methods of sterilization, or, in hormone insensitive tumors only, oral, subcutaneous or transvaginal hormonal, non-estrogen containing contraceptives)

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Charite University, Berlin, Germany

**Name:** Jalid Sehouli

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** Related Info

**URL:** http://www.noggo.de

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000010049

- Term: Ovarian Diseases

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000091662

- Term: Genital Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000006058

- Term: Gonadal Disorders

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12974

- Name: Ovarian Neoplasms

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M1704

- Name: Carcinoma, Ovarian Epithelial

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12972

- Name: Ovarian Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9163

- Name: Gonadal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T4352

- Name: Ovarian Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: T4354

- Name: Ovarian Epithelial Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

### Condition Browse Module - Meshes

- ID: D000010051

- Term: Ovarian Neoplasms

- ID: D000077216

- Term: Carcinoma, Ovarian Epithelial

### Intervention Browse Module - Ancestors

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

### Intervention Browse Module - Browse Leaves

- ID: M19537

- Name: Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M18650

- Name: Carboplatin

- Relevance: LOW

- As Found: Unknown

- ID: M314

- Name: Epoetin Alfa

- Relevance: LOW

- As Found: Unknown

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017239

- Term: Paclitaxel

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Paclitaxel

**Description:** Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®

**ID:** EG000

**Other Num Affected:** 105

**Other Num at Risk:** 105

**Serious Number Affected:** 13

**Serious Number At Risk:** 105

**Title:** Paclitaxel

**Frequency Threshold:** 0

#### Other Events

**Term:** Anemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** Medra

#### Serious Events

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** Medra

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 105

**Num Events:** 3

**Term:** Death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** Medra

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 105

**Num Events:** 1

**Term:** Disease progression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** Medra

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 105

**Num Events:** 1

**Term:** Suspected thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** Medra

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 105

**Num Events:** 2

**Term:** Ileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** Medra

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 105

**Num Events:** 3

**Term:** deterioration of general condition

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** Medra

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 105

**Num Events:** 5

**Term:** embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** Medra

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 105

**Num Events:** 4

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 105

**Units:** Participants

### Group

**ID:** BG000

**Title:** Paclitaxel

**Description:** Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 23.4

**Upper Limit:** 80.3

**Value:** 60.4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 105

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 105

**Class Title:** Germany

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Gender
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** jalid.sehouli@charite.de
**Organization:** Charite Campus Vichow Klinikum
**Phone:** +49 30-450564052
**Title:** Prof. Dr. Jalid Sehouli
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 25.4
- **Spread:** 
- **Upper Limit:** 40.0
- **Value:** 28.8
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 105
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Time to progression
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** every 3 months for up to 3 years
**Title:** Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%
**Type:** PRIMARY
**Unit of Measure:** months
##### Group
**Description:** Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
**ID:** OG000
**Title:** Paclitaxel
#### Outcome Measure 2
**Description:** defined as hematological and non-hematological adverse events of grade \>= grade 1
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years
**Title:** Toxicity
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
**ID:** OG000
**Title:** Paclitaxel
### Participant Flow Module
#### Group
**Description:** Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
**ID:** FG000
**Title:** Paclitaxel
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 105
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 105
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Recruitment Details:** recruitment period: July 2003 - December 2004
**Has Results:** True